Lexaria Bioscience Corp. (NASDAQ: LEXX) Tracking Proprietary Path to Drug Delivery Innovation and Commercialization on Robust R&D Programs

  • Lexaria Bioscience is a global innovator in drug delivery platforms
  • The company has been developing and commercializing patented DehydraTECH(TM), a technology that has been shown to increase the bioavailability of fat-soluble active molecules, improve the speed of onset and provide other benefits across multiple applications
  • Lexaria has undertaken numerous R&D programs in an effort to build relationships with prospective corporate partners to out-license the technology or to form other profitable corporate relationships
  • The company owes its achievements to its focus on R&D and the guidance provided by its highly experienced leadership, including CEO Chris Bunka, President John Docherty, as well as a dedicated and active board of directors

Lexaria Bioscience’s (NASDAQ: LEXX) path to becoming a global leader and innovator in drug delivery traces its origins to 2014, when CEO Chris Bunka redirected the company to its current business, focusing on the research and development (“R&D”) of the delivery of lipophilic active molecules based on its patented DehydraTECH(TM) technology. Protected by 28 granted patents worldwide, with many more pending around the world, the technology can lay claim to the potential of disrupting the drug delivery space as it is known today.

Typically, a drug delivery system is a formulation or a device that enables the introduction of a therapeutic substance into the body. It is specifically designed to improve the substance’s efficacy and safety by controlling the rate, time, and place of release of drugs in the body. Over the years, drug delivery scientists have been on a quest to improve the existing systems, leading to the introduction of nanoparticles, emulsifiers, and microalgae-based oral microcarriers  (https://cnw.fm/pOxn6), just to name a few.

This quest is informed in large part by the shortcomings of existing systems. And as Lexaria has established, these systems are not particularly effective at delivering as much of the drug as possible into the bloodstream for use by the body; to put it more technically, they have low bioavailability. Additionally, the company has observed that drugs, especially fat-soluble active pharmaceutical ingredients (“APIs”), take a considerable time to start working when delivered using the existing systems.

In light of the evident shortcomings, Lexaria has been developing DehydraTECH, a platform technology that enhances the performance of several categories of fat-soluble active molecules and drugs across oral and/or topical formats. DehydraTECH, the company explains on its website, is an additional step that is easily and seamlessly incorporated into the formulation and manufacturing process of existing or new products.

“This step involves mixing the active ingredients as a delivery ‘payload’ together with certain fatty acids, infusing the mixture into a substrate material, and then using controlled dehydration synthesis processing to associate the payload and fatty acids together at a molecular level, before integrating the newly combined molecules into end-product production across a range of dosage form factors,” the website continues (https://cnw.fm/1ENF0).

The result? The improved and more rapid absorption of active molecules into the bloodstream and brain tissue. This benefit, according to Lexaria, stems from the fact that DehydraTECH works symbiotically with existing physiological systems, thus enabling better bioavailability and bio-absorption. Another result is that fat-soluble molecules processed using the DehydraTECH technology become masked to oral and olfactory receptors, rendering them mostly flavorless and odorless.

Since 2014, Lexaria has undertaken multiple R&D programs covering such DehydraTECH-processed active molecules as nicotine, cannabidiol (“CBD”), and antiviral drugs (https://cnw.fm/68qUh). These initiatives have not only proven the above results to be true but also opened up additional commercialization opportunities.

“Our applied R&D is paying off in spades because we are currently in active discussions with several multi-billion dollar companies around the world, for the potential use of Lexaria’s DehydraTECH technology in their commercial product pursuits,” Bunka wrote in the annual CEO letter to shareholders published January 2023 (https://cnw.fm/CYLvm). “It is a direct result of our positive R&D programs that, as 2023 begins, we are actively involved in several sets of ongoing discussions and due diligence proceedings with potential corporate partners with a goal of collaboration, DehydraTECH out-licensing, or other corporate relationships.”

Additionally, the company is working toward an Investigational New Drug (“IND”) application that will seek FDA’s approval to undertake Phase 1(b) registered trial evaluating DehydraTECH-CBD as a potential treatment for hypertension. The study, which will seek to uncover the safety and tolerability of the formulation, is expected to begin this year.

Lexaria’s accomplishments so far can be attributed largely to the guidance of CEO, Chairman and Director Chris Bunka, President and Director John Docherty, and the company’s board of directors with members who have decades of experience in public and private businesses.

For instance, Dr. Catherine C. Turkel, Pharm.D, Ph.D., has over 20 years’ experience as an executive in startup and mid-size pharma or biotech companies. Having previously served as Founder and CEO of Nezee Therapeutics and President and R&D Head at Novus Therapeutics, since renamed Eledon Pharmaceuticals (NASDAQ: ELDN), she has formulated registration and commercial strategic plans and spearheaded global development programs for pharmaceutical and biologic treatments from phase 1 through phase 4 (https://cnw.fm/Lq14l).  Her experience will, therefore, be invaluable as Lexaria conducts its planned FDA clinical trials.

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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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) Strengthens Board of Directors to Boost Efforts toward Regulatory Approval of Potential Treatment for Hypertension

  • Lexaria Bioscience is a global innovator in drug delivery platforms whose lead technology, DehydraTECH, has been shown to increase the bioavailability of APIs
  • The company recently announced that Catherine Turkel, PharmD, Ph.D., has joined its board of directors
  • Dr. Turkel, who brings over 20 years’ experience, has previously formulated Food and Drug Administration (“FDA”) registration and commercial strategic plans, as well as led global development programs for pharmaceutical and biologic treatments
  • Dr. Turkel will lend her drug registration experience and regulatory expertise to Lexaria at a time when the company is journeying toward regulatory approval for DehydraTECH-CBD, its drug candidate for the treatment of hypertension
  • Lexaria recently had a pre-IND meeting with the FDA, where it received positive feedback

Companies should bring on board members with strategic growth experience who have “been there, done that,” a June 2022 article in Forbes advises (https://cnw.fm/MUABF). Strategic growth, the article observes, “is one of the most important areas of governance for boards. The more experience on a board, the more efficient you are at developing tried and tested growth strategies… Members with experience down certain paths can guide a company to anticipate and avoid known obstacles, helping to accomplish goals faster.”

As Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, charts the long path toward regulatory approval for DehydraTECH(TM)-processed cannabidiol (“CBD”), a prospective treatment for hypertension, the importance of bringing on board members with prior drug registration experience as well as regulatory expertise is not lost on the company. Lexaria recently announced that Catherine Turkel, PharmD, Ph.D., has joined its board of directors (https://cnw.fm/VoiEe).

With more than 20 years’ experience, Dr. Turkel has worked as an executive in start-up and mid-size pharma/biotech companies. She founded and was the CEO of Nezee Therapeutics, served as the President and R&D head at Novus Therapeutics – which has been renamed Eledon Pharmaceuticals Inc. (NASDAQ: ELDN) – and currently serves as an independent Board Director at private company Object Pharma and non-profit Prostate Cancer Research. She is also a Dean Advisor at Chapman University School of Pharmacy.

Dr. Turkel has formulated Food and Drug Administration (“FDA”) registration and commercial strategic plans and spearheaded global development programs for pharmaceutical and biologic treatments from Phase 1 through Phase 4 across such therapeutic areas as otology, urology, aesthetics, ophthalmology, rare diseases, psychiatry, cardiovascular, neurosciences, and pain. At a previous stint working with Allergan – now a part of AbbVie (NYSE: ABBV) – Dr. Turkel designed and led the pharmaceutical company’s BOTOX(R) Chronic Migraine registration program, leading to revenue of over a billion dollars.

“Lexaria is delighted to welcome Dr. Turkel as we continue to position the company for advancement following our recent successful pre-IND (pre-investigational new drug) meeting with the FDA,” commented Lexaria Chair and CEO Chris Bunka. “Catherine’s practical development and regulatory expertise will be of increasing value to Lexaria, and we look forward to working with her.”

The onboarding of Dr. Turkel comes on the heels of a Pre-IND meeting regarding Lexaria’s DehydraTECH-CBD for the treatment of hypertension. Reporting that the meeting had yielded positive feedback from the FDA, the company’s August 10 announcement noted that the FDA had seconded its proposal to pursue an abbreviated regulatory pathway that would enable a faster route to commercial approval (https://cnw.fm/ilZ4B). In addition, the FDA favorably received the company’s proposed Phase 1b clinical trial protocol that will involve ~100 patients with hypertension with the intention of opening the IND application to allow Lexaria to work toward full registration of its potential treatment.

“As a result of the favorable FDA response, Lexaria expects to remain on track to file its full IND application with the FDA by late 2022/ early 2023, as previously announced. This is up to 6-9 months sooner than if the FDA had required modifications in Lexaria’s current IND-enabling work plan, such as performance of additional non-clinical study work,” the August 10 news release reads.

Lexaria has shown, through human testing, that DehydraTECH-processed CBD delivers promising results with no serious adverse effects. In 2018, the company administered the substance to 12 participants in a human clinical study (“HCS”) that evidenced 317% more CBD delivered to the blood at 30 minutes than controls. Moreover, three HCSs conducted in 2021, HYPER-H21-1, HYPER-H21-2, and HYPER-H21-3, evidenced rapid and sustained drop in blood pressure, a 23% average drop in overnight blood pressure and reduced arterial stiffness, and attenuated pulmonary artery systolic pressure, respectively (https://cnw.fm/MHOCj).

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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CannabisNewsBreaks – Lexaria Bioscience Corp. (NASDAQ: LEXX) Appoints New Board Member

Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug-delivery platforms, has announced an addition to its board of directors; the company named industry veteran Catherine Turkel, PharmD, PhD, as the newest member of its board. Turkel brings more than two decades of experience as an executive-level leader in both start-up and mid-size pharma/biotech companies. As founder and CEO of Nezee Therapeutics, she gained critical expertise and insight in the space; she also served as president and head of research and development Novus Therapeutics, which was later renamed Eledon Pharmaceuticals Inc. (NASDAQ: ELDN). Currently she serves as an independent board director at Object Pharma and advisory committee member at nonprofit Prostate Cancer Research; she is also a dean advisor at Chapman University School of Pharmacy. In her various roles, Turkey has led and executed FDA registration and commercial strategic plans as well as global development programs; she has invaluable experience in a range of sectors, including neurosciences, pain, cardiovascular, psychiatry, rare diseases, ophthalmology, aesthetics, urology and otology therapeutic areas. In addition, Turkel designed and led an innovative BOTOX(R) chronic migraine registration program for Allergan, now AbbVie Inc. (NYSE: ABBV), which generated more than a billion dollars. “Lexaria is delighted to welcome Dr. Turkel as we continue to position the company for advancement following our recent successful pre-IND meeting with the Food and Drug Administration,” said Lexaria board chair Chris Bunka in the press release. “Catherine’s practical development and regulatory expertise will be of increasing value to Lexaria, and we look forward to working with her.”

To view the full press release, visit https://cnw.fm/JroKp

About Lexaria Bioscience Corp.

Lexaria Bioscience’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 about the company, please visit 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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