• Lexaria, a global innovator in drug delivery platforms, has developed the patented DehydraTECH(TM) platform technology, which has been shown to increase the bio-absorption of various fat-soluble active molecules and drugs
• In a recently completed study, Lexaria showed that DehydraTECH-processed CBD had exceptional safety and tolerability profile in addition to resulting in a statistically significant lowering of 24-hour ambulatory blood pressure
• The company also reported that it had demonstrated superior CBD blood absorption levels in its HYPER-H21-4 study from DehydraTECH-CBD relative to those of published comparators
• At the lowest (3.38 mg/kg) and highest (4.46 mg/kg) dose levels tested, DehydraTECH-CBD resulted in 45.8% and 133.4% higher average blood plasma levels, respectively, than the figure reported when a higher (5 mg/kg) dose level of non-Lexaria, pharmaceutical-grade CBD was administered

Global innovator Lexaria Bioscience (NASDAQ: LEXX) has developed a proprietary platform technology that is capable of delivering certain drug molecules more effectively into the human body than their generic forms. That, CEO Chris Bunka contends (https://cnw.fm/FEXdl), allows for various efficiencies and decreases in adverse side effects.

Known as DehydraTECH(TM), the patented technology can be easily incorporated into the formulation and manufacturing processes of existing or new orally ingestible and topical products, according to the company, provided the products are fat soluble. So far, Lexaria has been able to process various active molecules and drugs, including antiviral drugs, nicotine, cannabidiol (“CBD”), vitamins, phosphodiesterase inhibitors, and more, using its DehydraTECH platform technology (https://cnw.fm/Sim8u). Moreover, the company has, as of December 29, 2022, received a total of 28 patents granted worldwide (https://cnw.fm/9C6eR) for several DehydraTECH-processed applications.

But what is even more remarkable is the fact that Lexaria has evidenced, through multiple animal and human studies, that its DehydraTECH platform technology increases bio-absorption by up to 10x, reduces the time of onset from as much as 1-2 hours to just minutes, delivers drugs more effectively into the bloodstream, and masks unwanted tastes. And in what adds to the company’s repository of the proven benefits of DehydraTECH, the company recently completed a randomized, double-blinded, placebo-controlled cross-over study of 66 male and female volunteers, its most comprehensive hypertension study yet.

Dubbed HYPER-H21-4, the study showed that DehydraTECH-processed CBD had an exceptional safety and tolerability profile. It also evidenced that the formulation resulted in a statistically significant lowering of 24-hour ambulatory blood pressure (“BP”), with the BP lowered for the entire five-week study duration. Furthermore, the BP lowered both for patients not taking any other antihypertensive drugs as well as those currently on antihypertensive medication (https://cnw.fm/TTxMQ).

At the time of announcing the results from this study, the company on October 27 stated that “additional study endpoint analyses as described in the complete study protocol are still underway and any relevant material findings will be reported upon in due course….” And in a December 21 news release, Lexaria reported on one of these findings.

According to this recent announcement, Lexaria reported that it had demonstrated superior CBD blood absorption levels from its patented DehydraTECH-CBD compared to those of published comparators. In their analysis, Lexaria’s researchers compared the average blood plasma levels of DehydraTECH-CBD at various dose levels (after the steady state or the amount of time needed before a consistent dose of drug achieves a stable plasma level had been reached) with that of non-Lexaria, pharmaceutical-grade CBD formulations published in two studies – a 2017 clinical trial and a 2019 study (https://cnw.fm/XGBhH).

The 2017 trial evidenced an average blood plasma CBD level of 23.0 ng/ml after 22 days (the steady state) of daily dosing at a 5 mg/kg non-Lexaria CBD dose level. Lexaria’s HYPER-H21-4 study, on the other hand, showed that the DehydraTECH technology resulted in a 45.8% higher average blood plasma level (33.3 ng/mL) at DehydraTECH-CBD’s lowest dose level tested of just 3.38 mg/kg. When the dose level was increased to 4.46 mg/kg (the highest in the test), the blood plasma level was 133.4% higher than in the 2017 study at 53.7 ng/mL.

On their part, the researchers in the 2017 study evaluated higher CBD dosing at a level of 10 mg/kg, showing a blood plasma level of 62.1 ng/mL. Lexaria’s HYPER-H21-4 study, however, did not see the need to administer a dose as high as 10 mg/kg, with the researchers instead extrapolating the administered dose levels linearly to 10 mg/kg. According to the resulting data trend, a 10 mg/kg dose of DehydraTECH-CBD would result in a plasma level of 149.5 ng/mL, a 141% improvement over the findings contained in the 2017 study.

Using the extrapolated data trend, Lexaria also showed that at a dose level of 10 mg/kg, the absorption resulting from the administration of DehydraTECH-CBD would outperform that of the pharmaceutical-grade, synthetic CBD formulation used in the 2019 study. The non-Lexaria synthetic CBD, the 2019 study showed, reached a blood plasma level of 91 ng/mL. By comparison, Lexaria’s linear extrapolation showed that DehydraTECH-CBD absorption would outperform this figure by 64%.

“DehydraTECH-CBD has repeatedly shown that it can be administered at much lower dose levels than other CBD formulations to achieve effective levels within the bloodstream, as supported by this pharmaceutical-industry peer comparison,” commented Bunka. “This is extremely important to patients hoping to achieve positive health outcomes while using lower levels of medication with no serious side effects and also important to Lexaria as we pursue FDA registration of DehydraTECH-CBD.”

Lexaria hopes to file an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) this year in anticipation of possible approval to proceed with registered clinical trials evaluating the safety, tolerability, and effectiveness of DehydraTECH-CBD in treating hypertension.

For more information, visit the company’s website at www.LexariaBioscience.com.

NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://cnw.fm/LEXX

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• The 36-person human pharmacokinetic randomized, double-blind, cross-over study NIC-H22-1 will compare its patented DehydraTECH(TM)-nicotine to leading nicotine pouches On! and Zyn
• The white pouch oral delivery of nicotine is thought to avoid harmful lung outcomes that smokers and vapers experience
• The global nicotine pouch market was valued at $2.33 billion in 2020 and is expected to reach $21.84 billion by 2027, driven by an increase in the number of consumers seeking alternative forms of nicotine that do not involve lung exposure

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, announced that dosing has commenced for its human clinical nicotine study NIC-H22-1. The study is a 36-person human pharmacokinetic randomized, double-blind, cross-over study conducted on current cigarette smoking subjects. Each participant will visit the laboratory and be dosed three times over the coming weeks. Only one oral nicotine pouch will be administered and evaluated during each visit. Participants will either receive Lexaria’s patented DehydraTECH(TM)-nicotine, On! brand manufactured by Altria, or Zyn brand manufactured by Swedish Match during that time (https://cnw.fm/QLXXQ).

The objectives of the NIC-H22-1 study are to determine the quantity of nicotine in blood at various time points and vital-sign data collection of temperature, blood pressure, heart rate, and respiratory rate. The company also plans to collect subjective evaluations, including throat burn, user experience, gastrointestinal experience, and more.

The global nicotine pouches market was valued at $2.33 billion in 2020 and is expected to reach $21.84 billion by 2027, growing at a CAGR of 30.7% during the forecast period (https://cnw.fm/ndfl1). Key market growth factors include a growing interest in nicotine pouches among those trying to quit smoking and the increased interest of consumers looking for alternative forms of nicotine that do not involve lung exposure.

The oral nicotine pouch category has become one of the fastest-growing segments of the nicotine industry due in part to a 2019 determination by the U.S. Food and Drug Administration (“FDA”) that stated the potential for “reduced risk health outcomes” (https://cnw.fm/d20a5). The delivery method, in the white pouch format specifically, is thought to avoid harmful lung outcomes experienced by smokers and vapers because it involves absorption primarily through the buccal tissues of the mouth using purified nicotine that has been separated from the other harmful compounds found within the tobacco leaf.

Lexaria’s patented DehydraTECH(TM) technology is designed for formulating and delivering lipophilic (fat-soluble) drugs and active ingredients. DehydraTECH(TM) increases effectiveness and improves how these ingredients enter the bloodstream. Benefits of DehydraTECH include:

• Improved speed of onset, with effects felt in minutes
• Increased bioavailability, with more of the drug delivered into the bloodstream
• Increased brain absorption, with testing suggesting up to 10x improvement
• Improved drug potency, with more of the ingested product made available in the bloodstream requiring lower dosages

Animal studies conducted by Lexaria have demonstrated a propensity for DehydraTECH(TM) technology to elevate the quantity of the drug delivered across the blood-brain barrier by as much as 1,900 percent, which has initiated new patent applications and has opened the possibility of improved drug delivery.

As of September 2022, Lexaria’s development of its patented DehydraTECH(TM) technology since 2014 has yielded over 50 pending patents in countries worldwide, along with 27 granted patents. Lexaria’s focused ongoing research and development efforts span several key segments, including tobacco, nicotine replacement, CBD, cardiovascular drugs, antivirals, epilepsy, human hormones, and PDE5 inhibitors.

For more information, visit the company’s website at www.LexariaBioscience.com.

NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://cnw.fm/LEXX

About CannabisNewsWire

CannabisNewsWire (CNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) CannabisNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, CNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. CNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, CNW brings its clients unparalleled visibility, recognition and brand awareness. CNW is where news, content and information converge.

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• Studies have indicated that around 40% of the available drugs on the market offer poor bioavailability
• Lexaria’s patented DehydraTECH(TM) technology increases bioavailability, improving the way active pharmaceutical ingredients (“APIs”) enter the bloodstream by promoting more effective oral delivery
• The global pharmaceutical drug delivery market was valued at $1.66 billion in 2021 and is expected to grow at a CAGR of 5.9%, resulting in a value of $2.21 billion by 2026

One of the main concerns associated with marketed drugs is low bioavailability. Bioavailability is the amount of a drug or substance that becomes completely available to the intended biological destination and is a measure of the rate and fraction of the initial dose of the drug that successfully reaches either the site of action or the bodily fluid domain in which the intended target has unimpeded access. Bioavailability is integral to pharmacokinetics, the study of drug movement through the body. Pharmacokinetics is often represented by the acronym ABCD – administration, bioavailability, clearance, and distribution (https://cnw.fm/29C2S).

Various studies have indicated that around 40% of available drugs are poorly bioavailable (soluble) (https://cnw.fm/mLG2Z). Many factors can affect the bioavailability of drugs and substances, including:

• The size of the drug’s molecule – smaller molecules are more easily absorbed into the body than larger ones
• The type of drug administered – some drugs are absorbed more easily through the stomach than others
• How much food is eaten – food can slow down the absorption process
• The time of day – the absorption of drugs can be affected by factors like the time of day or the mood of the recipient

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, has developed a patented technology, DehydraTECH(TM), which improves the bioavailability of active pharmaceutical ingredients (“APIs”), promotes healthier oral ingestion methods and increases the effectiveness of fat-soluble active molecules. DehydraTECH technology is suitable for use with various product formats, including pharmaceuticals, nutraceuticals, consumer packaged goods, and over-the-counter capsules, pills, tablets, and oral suspensions. Currently, DehydraTECH-CBD is being studied for the potential treatment of hypertension and heart disease, epilepsy, dementia and diabetes.

Lexaria’s DehydraTECH solves common problems experienced in the pharmaceutical industry. DehydraTECH technology can increase bioabsorption by up to 10x, reduce the onset time from up to 1-2 hours to just minutes, mask the unwanted taste, delivers drugs into the bloodstream more effectively, and provides a higher ratio of drug delivery expected to lower overall drug costs.

The global pharmaceutical drug delivery market size is projected to reach $2.21 billion by 2026, growing at a CAGR of 5.9%. The market was valued at $1.66 billion in 2021. This growth is highly attributed to factors including the rising prevalence of chronic diseases, the growing biologics market, increased R&D investments, and technological advancements – including new product launches (https://cnw.fm/PjBnG).

Understanding the bioavailability of a drug is crucial for clinicians looking for the most appropriate route of administration and schedule for delivering the drug. Lexaria is currently studying its DehydraTECH and DehydraTECH-CBD for indications including epilepsy, high blood pressure, dementia, diabetes and more.

The company’s most recent study, EPIL-A21-1, demonstrated performance enhancements compared to one of the world’s leading anti-seizure medications, Epidiolex(R). The study’s results have demonstrated the performance of DehydraTECH-CBD to reduce or eliminate seizure activity in animals and, in some cases, even surpass the performance of Epidiolex. These findings further support Lexaria’s efforts and clinical trials, which are currently being explored for hypertension, dementia, diabetes and other indications where DehydraTECH technology may offer solutions in indications where there is an underserved medical need.

For more information, visit the company’s website at www.LexariaBioscience.com.

NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://cnw.fm/LEXX

About CannabisNewsWire

CannabisNewsWire (CNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) CannabisNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, CNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. CNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, CNW brings its clients unparalleled visibility, recognition and brand awareness. CNW is where news, content and information converge.

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• Epilepsy affects one in every 26 people globally, with as many as one million ED visits, 280 hospital admissions, average hospital stays of 3.6 days, and an aggregate hospital cost of approximately $2.5 billion annually
• With its severity, prevalence, and overall cost implications, Lexaria is looking to offer an alternative option with its patented DehydraTECH(TM)-CBD
• Its recent animal seizure study, EPIL-A21-1, showed DehydraTECH-CBD to be equally or even more effective at lower doses than Epidiolex, one of the world’s leading anti-seizure medications and the world’s only commercially approved CBD-powered anti-seizure drug
• Lexaria looks to build on the findings so far to establish a better understanding of DehydraTECH-CBD for the potential treatment of seizures, a market projected to be valued at $16.6 billion by 2031

According to the Epilepsy Foundation, epilepsy is the fourth most common neurological condition globally, affecting one in every 26 people. About 48 out of every 100,000 people are diagnosed with the condition every year, and as of 2019, it affected approximately 50 million people (https://cnw.fm/OGF3x). With the condition leading to as many as one million emergency department (“ED”) visits and over 280,000 hospital admissions, it attracts average hospital stays of 3.6 days for the patients, with an aggregate hospital cost totaling approximately $2.5 billion annually (https://cnw.fm/Mlp9d).

Given the severity, prevalence, and overall cost implications associated with this condition, there is a dire need for treatment options that are not only effective but also affordable. Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, seeks to meet that need with its patented DehydraTECH(TM)-CBD.

In a recent animal seizure study, EPIL-A21-1, designed to establish whether DehydraTECH-CBD could provide similar seizure-inhibiting efficacy at lower doses than that required with Epidiolex, Lexaria’s technology proved to reduce or even eliminate seizure activity in animals. In some cases, it also surpassed the performance of Epidiolex, one of the world’s leading anti-seizure medications. Epidiolex is also the world’s only commercially approved CBD-powered anti-seizure drug. However, in the study, Epidiolex seemed more effective at higher doses compared to DehydraTECH-CBD (https://cnw.fm/RxXp3).

Lexaria is always searching for the lowest possible efficacious dose levels of the drugs it formulates with DehydraTECH in order to minimize adverse side effects.  At lower doses of 50 mg/kg and 75 mg/kg, DehydraTECH proved to be more efficacious than Epidiolex in reducing or eliminating seizure activity, with complete elimination of seizure activity in 66.6% of the animals compared to 50% of Epidiolex-treated animals.

The company looks to build on the findings so far to better understand DehydraTECH-CBD for the potential treatment of seizures, a market, projected to be valued at $16.6 billion by 2031, up from $10.6 billion in 2021.

Lexaria is still considering the optimization of its DehydraTECH-CBD formulation for the reduction or overall elimination of seizure activity and is proud of the progress made thus far. The success of this study adds to the company’s successful streak, with recent positive developments in its hypertension human clinical study program, along with dementia and diabetes studies that kicked off in November.

For more information, visit the company’s website at www.LexariaBioscience.com.

NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://cnw.fm/LEXX

About CannabisNewsWire

CannabisNewsWire (CNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) CannabisNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, CNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. CNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, CNW brings its clients unparalleled visibility, recognition and brand awareness. CNW is where news, content and information converge.

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• Lexaria Bioscience is a global innovator in drug delivery platforms whose patented DehydraTECH(TM) technology has demonstrated the ability to improve the bioavailability and increase the speed of onset of many drugs
• In calendar 2022, the company achieved a number of milestones in various areas, including research programs, receipt of patents, and licensing agreements
• Lexaria started and completed its fourth and most comprehensive hypertension study yet, investigating the capabilities of DehydraTECH-CBD, with the study showing that its formulation resulted in a sustained reduction in blood pressure over the study period (five weeks)
• The company has also started investigating DehydraTECH-CBD as a potential therapeutic for the treatment of dementia and diabetes and is planning to begin another study on DehydraTECH-nicotine pouch performance
• Over the course of the year, Lexaria was granted four new patents, and entered into separate licensing agreements with four new partners

In his concluding remarks in this year’s letter to shareholders published January, Lexaria Bioscience (NASDAQ: LEXX) CEO Chris Bunka underlined that “Management of [the company] feels we are on track, on schedule, and on budget to deliver what we hope and expect will be great results in 2022” (https://cnw.fm/gfw3L). Since then, the company has achieved crucial milestones that can well be described as “great results,” and rightly so. These milestones are centered around Lexaria’s patented DehydraTECH(TM) drug delivery technology.

DehydraTECH can be applied to many drugs and fat-soluble active pharmaceutical ingredients (“APIs”), with the resultant formulation boasting better speed of onset, bioavailability, and brain absorption. So far, Lexaria has evidenced, through pharmacokinetic (“PK”) studies, that its technology delivers higher quantities of cannabidiol (“CBD”), oral nicotine, and antiviral drugs into the bloodstream in less time, properties that are technically known as increased bioavailability.

For Lexaria, however, the end goal does not only lie in uncovering DehydraTECH’s ability to improve the bioavailability of various APIs. Instead, the company is keen on establishing whether DehydraTECH can be applied broadly within the pharmaceutical industry. And calendar 2022 has brought the company closer to realizing this goal, with the company initiating a slew of research programs, many of which it has already completed. Moreover, its intellectual property (“IP”) portfolio has received additional patent protection in different jurisdictions around the world. Lexaria has also entered into multiple manufacturing and/or licensing agreements with global partners.

Research Programs

DehydraTECH-Processed PDE5 Inhibitor

Lexaria kicked the year off with an announcement of ground-breaking findings in an animal study evaluating DehydraTECH-processed sildenafil, a phosphodiesterase (“PDE5”) inhibitor used in the management of erectile dysfunction. The study, whose results were announced February 2, showed that the DehydraTECH formulation delivered more sildenafil (roughly 70% more drug) and at a faster rate (about 25% faster) than the concentration-matched, generic control formulation (https://cnw.fm/SnLRR).

DehydraTECH-Processed CBD

In 2022, much like in 2021, Lexaria’s biggest area of investigation was CBD – or, more specifically, DehydraTECH-processed CBD. The company expanded the scope of its research to include not only investigations on hypertension or high blood pressure, a condition on which it had completed two human studies (HYPER-H21-1 and HYPER-H21-2) the year prior, but also diabetes, seizures, and dementia.

Building on the HYPER-H21-1 study, a 24-person study that evidenced a rapid and sustained drop in blood pressure, and HYPER-H21-2, which showed that DehydraTECH-CBD caused a 23% average reduction in overnight blood pressure and reduced arterial stiffness, Lexaria also released the findings of its 16-person HYPER-H21-3 study in April this year. This third study evidenced that the pulmonary artery systolic pressure was attenuated by about 5 mmHg or 41% overall in male participants (https://cnw.fm/w5iOL).

The positive findings from the HYPER-H21-3 study set the stage for the commencement of the fourth human clinical study (“HCS”), HYPER-H21-4, the most comprehensive study Lexaria has ever undertaken, that same month (https://cnw.fm/IlHTK). A 66-person randomized, double-blinded, placebo-controlled, cross-over study, HYPER-H21-4 was designed as a multi-week study whose dosing was completed in July with no serious adverse events reported. That was a vital outcome given that the main objective of most FDA-registered Phase I studies is to prove safety and tolerability.

This news was a precursor to even more positive news reported in late October when Lexaria announced that HYPER-H21-4 “may be the world’s first study to evidence a sustained drop in blood pressure (“BP”) in normally active hypertensive patients following multiple weeks of oral CBD therapy, using Lexaria’s patented DehydraTECH-CBD capsule formulation.”

The study showed a significant BP reduction by 2.5 weeks, with this attenuation sustained over the entire five weeks of dosing. Moreover, Lexaria also observed that the decreases in BP were similar in persons receiving treatment with standard-of-care BP medication as in persons who were not undergoing any current treatment, suggesting DehydraTECH-CBD’s potential abilities to offer additive BP reduction benefits above and beyond the therapeutic improvements of standard BP medication. This can have important regulatory implications.

“That we were able to lower blood pressure in our patient population over multiple weeks using DehydraTECH-CBD is an exceptional discovery, given that previous studies by others using other oral CBD formulations have failed to evidence this sustained benefit,” Chris Bunka commented. “DehydraTECH also demonstrated excellent safety and tolerability results and no adverse changes in liver enzymes throughout the study. Indeed, of the handful of minor, non-serious adverse events reported, there were nearly as many reported by those patients receiving placebo as those who received DehydraTECH-CBD.”

HYPER-H21-4 was designed to enhance Lexaria’s probability of success with its expected Investigational New Drug (“IND”) application to seek the US Food and Drug Administration (“FDA”) approval to begin registered clinical testing. Against the backdrop of the findings from this study, and having already received positive feedback from a pre-IND meeting with the FDA, according to an August press release (https://cnw.fm/lZ2Eo), Lexaria is on track to file the full IND application in 2023. (Following the pre-IND meeting, the FDA confirmed its support for an abbreviated approval pathway in line with section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.)

Meanwhile, in a separate three-part animal study that kicked off in March that aimed to assess the effectiveness of DehydraTECH-CBD in reducing seizure activity compared to the FDA-approved seizure medication Epidiolex (https://cnw.fm/hHsfv), Lexaria evidenced that DehydraTECH-CBD can be more efficacious at lower doses than Epidiolex. Additionally, the company observed that DehydraTECH-CBD can act more rapidly than Epidiolex. According to Lexaria, work is ongoing to complete the third and final part of the study that intends to establish the dose required to achieve seizure inhibition in 50% of the animals tested or ED50 (https://cnw.fm/cKuVx).

In addition to the hypertension and seizure studies, Lexaria recently commenced separate investigations on the potential therapeutic use of DehydraTECH-CBD in both diabetes and dementia. Dubbed DIAB-A22-1, the study investigating  DehydraTECH-CBD’s potential utility in the treatment of diabetes kicked off on November 8 (https://cnw.fm/LV8q6), while DEM-A22-1, the study on the potential use of DehydraTECH-CBD in dementia, begun a couple of days later on November 10 (https://cnw.fm/sZQLD).

DehydraTECH-Processed Nicotine

Calendar 2022 also marked the year when Lexaria began expanding its research on nicotine to include human subjects. Having resolved the manufacturing and logistics challenges that had previously pushed back the commencement time as well as having received Independent Review Board (“IRB”) approval for the planned human oral nicotine study, NIC-H22-1, Lexaria expects to begin dosing in December 2022 (https://cnw.fm/m0Zuy).

A 36-person human PK, randomized, double-blinded, cross-over-study carried out in current cigarette smokers, NIC-H22-1 will see each participant receiving only one brand of oral nicotine pouch on each of the three visits to the laboratory over a period of weeks. Upon administration, each person will undergo both subjective and objective evaluations, with vital signs such as respiratory rate, heart rate, blood pressure, and temperature also collected. Overall, the study is specifically designed to compare the performance of Lexaria’s DehydraTECH-nicotine pouch to On!’s (a pouch brand manufactured by Altria) and Zyn’s (the world’s leading nicotine pouch product manufactured by Swedish Match).

Competition in the nicotine pouch category is heating up, with PMI have just completed its US$16 billion acquisition of Swedish Match.

Previously, Lexaria had demonstrated in animal study NIC-A21-1 that oral nicotine pouches processed using DehydraTECH were 10 to 20 times faster in reaching peak delivery of nicotine to the bloodstream than controls.

Patents

In 2022, Lexaria continued to strengthen its intellectual property portfolio, receiving four new patents as described below:

• In March, Australia granted Lexaria a patent entitled “Compositions Infused with Nicotine Compounds and Methods to Use Thereof” that covers most oral forms of nicotine, including sprays, gums, pouches, capsules, lozenges, tablets, and pills. The patent also covers various forms of nicotine, including free base nicotine, polymer resins of nicotine, nicotine salts, and other forms of nicotine complexes (https://cnw.fm/jYD7f).
• In April, the United States Patents and Trademark Office (“USPTO”) granted Lexaria its first-ever patent for using DehydraTECH technology to enhance the delivery of antiviral drugs (https://cnw.fm/T8LzG).
• In July, Lexaria received its fourth patent granted in Japan, entitled “Lipophilic Active Agent Infused Compositions with Reduced Food Effect,” which acknowledges the ability of DehydraTECH to deliver APIs more effectively regardless of the presence of foods within the gastrointestinal
• system (https://cnw.fm/XFvd4). 
• In August Lexaria received a new patent in Mexico that covers multiple claims, including but not limited to the treatment of hypertension, neurological diseases, diabetes, hepatic diseases, and more (https://cnw.fm/Pw52T).

With the receipt of the four patents in 2022, Lexaria now has 27 worldwide patents granted, with about 50 more patents pending worldwide. The company believes that should the remaining patent applications become granted patents, its ability to generate meaningful license revenue from its IP may increase from multiple other countries and regions outside of the United States. And if this year’s licensing agreements are anything to go by, Lexaria is progressively inching closer to this goal, one partner at a time.

Licensing Agreements

Generally, the company’s granted patents help to buttress a part of the company’s business plan, which according to its latest annual report, is to “encourage new and existing participants to license and utilize DehydraTECH to enable enhanced performance of their products” (https://cnw.fm/NhHJh). To that end, this calendar year saw the company onboard new partners who have licensed the DehydraTECH technology for use in their respective markets. Anchored in licensing agreements announced in June, the licenses include:

• A European and United Kingdom DehydraTECH license for medical cannabis applications from wholly owned subsidiary Lexaria Pharmaceutical Corp. to Valcon Medical A/S, a European contract manufacturing organization (“CMO”) that manufactures medical cannabis extracts for the European Union (“EU”) and the UK (https://cnw.fm/e58yq) 
• An exclusive commercial licensing agreement granted to Premier Wellness Science Co. Ltd. for the Japanese non-pharmaceutical market for the use of DehydraTECH with CBD and hemp ingredients in oral liquid and non-liquid products, topical, hair, lip-care, and cosmetics products (https://cnw.fm/SVWi8)
• A five-year, non-exclusive DehydraTECH license to AnodGen Bioceuticals of Ireland, a CMO, for the manufacturing and distribution of DehydraTECH-processed cannabinoid API powders within Europe, Australia, and New Zealand (https://cnw.fm/enV29)
• Two agreements – a manufacturing operating agreement and a commercial license agreement – with Atlanta-based BevNology LLC. (https://cnw.fm/XO2UL)

For more information, visit the company’s website at www.LexariaBioscience.com.

NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://cnw.fm/LEXX

About CannabisNewsWire

CannabisNewsWire (CNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) CannabisNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, CNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. CNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, CNW brings its clients unparalleled visibility, recognition and brand awareness. CNW is where news, content and information converge.

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Lexaria Bioscience Corp. (NASDAQ: LEXX), a global leader in enhancing the speed and efficiency of orally delivered fat-soluble active molecules and drugs, has, since inception, been committed to addressing severe unmet patient needs. Hypertension has been one of its main focus areas. “Lexaria continues to move forward, most recently with the success in its latest human clinical study, HYPER-H21-4. The study may be the first to evidence a sustained drop in blood pressure in normally active patients following multiple weeks of oral cannabidiol (‘CBD’) therapy using the company’s patented DehydraTECH(TM) technology,” reads a recent article. “Since Lexaria began developing DehydraTECH in 2014, it has continued to strengthen and broaden the technology, exploring various areas including but not limited to the oral administration of antivirals, cannabinoids, vitamins, nicotine, and PDE5 inhibitors. In early 2021, it began dosing in its first human clinical study that assessed its DehydraTECH-enabled CBD capsule formulation. This would lay the groundwork for subsequent studies while also bolstering the company’s growing list of patents, which currently stands at 27, spread across the world, including the use of DehydraTECH-processed CBD for the treatment of heart disease.”

To view the full article, visit https://cnw.fm/drbOF

About Lexaria Bioscience Corp.

Lexaria’s patented drug delivery technology, DehydraTECH(TM), improves the way active pharmaceutical ingredients (“APIs”) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 27 patents granted and roughly 50 patents pending worldwide. For more information, visit the company’s website at www.LexariaBioscience.com.

NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://cnw.fm/LEXX

About CannabisNewsWire

CannabisNewsWire (CNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) CannabisNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, CNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. CNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, CNW brings its clients unparalleled visibility, recognition and brand awareness. CNW is where news, content and information converge.

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• Approximately 55 million people worldwide have dementia, which is expected to grow to 78 million by 2030
• The dementia treatment market was valued at $13.78 billion in 2021. The market is expected to grow at a CAGR of 8.32%, resulting in a value of $26.13 billion by 2029
• Clinical studies have established a connection between hypertension and dementia
• With DehydraTECH(TM)-CBD already evidencing that it can lower blood pressure  and its propensity to cross the blood-brain barrier, Lexaria is investigating the potential for a positive outcome in the DEM-A22-1 study

According to the World Health Organization (“WHO”), dementia is the seventh leading cause of death among all diseases and one major cause of disability and dependency among older people worldwide. Dementia is characterized by the deterioration of cognitive function, affecting memory, thinking, orientation, comprehension, calculation, learning capacity, language, and judgment. Although consciousness is not impaired, it is commonly accompanied by mood changes, emotional control deficits, behavior changes, and motivational impairments. It is estimated that approximately 55 million people have dementia worldwide, a number expected to grow to 78 million by 2030 (https://cnw.fm/lYnyd).

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, is exploring its patented DehydraTECH(TM)-processed cannabidiol (“CBD”) for use against dementia. As previously evidenced in animal studies, DehydraTECH-CBD crosses the blood-brain barrier much more effectively than originally thought possible.

Clinical studies have established a connection between hypertension and dementia – individuals who have high blood pressure are more likely to develop vascular dementia, which is the second most common form of dementia, following Alzheimer’s Disease. Vascular dementia is caused by a reduced blood flow to the brain, starving brain cells of oxygen and nutrients needed to function properly. Previous studies of DehydraTECH-CBD for potential hypertension treatment have proved successful with no adverse reactions experienced by subjects in the human trials.

The company recently announced the launch of its first-ever study to investigate DehydraTECH-CBD and dementia (DEM-A22-1). Given the propensity of DehydraTECH-CBD to cross the blood-brain barrier, the established fact that it lowers human blood pressure, and CBD’s vasodilation properties, Lexaria is eager to investigate the potential of DehydraTECH-CBD’s positive effects on dementia (https://cnw.fm/6bEnw).

Based on research conducted by Maximize Marketing Research (“MMR”), the dementia treatment market was valued at $13.78 billion in 2021. The market is expected to grow at a CAGR of 8.32%, resulting in a value of $26.13 billion by 2029. An increase in R&D expenditures, increased frequency of Alzheimer’s Disease indications, a surge in the geriatric population, an upsurge in awareness about neurodegenerative diseases in emerging countries, and a rich pipeline of new treatment alternatives are expected to drive the market during the forecast period (https://cnw.fm/KoFRj).

The DEM-A22-1 study is a dose-ranging, two-month program involving a total of 32 Long Evans rats that will be dosed with DehydraTECH-CBD. A novel object recognition test, commonly used to assess memory in rodents, is being used to investigate whether CBD enables cognitive performance enhancements in the test model. The study is being undertaken by a third-party testing laboratory in Canada, with expected completion in late January 2023, with data and reporting to follow shortly after. Depending on the study’s outcome, additional investigation into DehydraTECH-processed nicotine (another agent evidenced to enhance cognitive performance) may follow. Lexaria will provide updates on DEM-A22-1 as they become available.

For more information, visit the company’s website at www.LexariaBioscience.com.

NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://cnw.fm/LEXX

About CannabisNewsWire

CannabisNewsWire (CNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) CannabisNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, CNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. CNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, CNW brings its clients unparalleled visibility, recognition and brand awareness. CNW is where news, content and information converge.

To receive instant SMS alerts, text CANNABIS to 21000 (U.S. Mobile Phones Only)

For more information please visit https://www.cannabisnewswire.com

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