Zelira Therapeutics has developed a medical marijuana insomnia product known as Thunderbird. Zelira Therapeutics was previously called Zelda Therapeutics (ASX: ZLD), and it changed its name after merging with the USA’s Ilera Therapeutics LLC late last year.
For the past few years, Zelda, currently known as Zelira Therapeutics, has been working on a marijuana product used for treating insomnia, ZLT-101. In 2017, Zelda Therapeutics obtained approval to conduct clinical trials with patients who have chronic insomnia in Australia. At the time of the merger, Zelda Therapeutics was also studying the use of marijuana in treating conditions such as autism, cancer, and opioid reduction, and it will continue to do so under the new company.
Zelira Therapeutics has operations both in the U.S. and Australia, and this gives it a robust platform in the global medical marijuana market.
On Wednesday, Zelira Therapeutics announced that it had completed phase 1b/2a of the clinical trials of ZLT-101. The study findings reveal that 23 patients who had chronic insomnia and were treated using ZLT-101 demonstrated statistical improvement in the Insomnia Severity Index (ISI) scores when they were compared with those who used the placebo. Patients who used ZLT-101 showed high tolerance since no adverse effects were reported.
Although ZLT-101 was well tolerated, some patients said that they experienced the following side effects; dry mouth, which was preceded by dizziness, headache, and feeling unwell. Out of the 23 patients using ZLT-101, 17 reported having experienced these mild side effects. Four participants who were placed on the placebo also said that they experienced the same side effects.
Zelira Therapeutics said that all adverse events that were noted during the clinical trials were classified as mild, and 97.5% of the cases had resolved overnight or as soon as the patient woke up the following day or were resolved at the end of the clinical trial.
Zelira said that lack of severe or persistent mild adverse cases is encouraging, given those linked with other insomnia therapies.
Prof. Peter Eastwood, who was the Principal Investigator for the study, said that it was impressive for the ZLT-101 treatment to achieve a statistically significant improvement in ISI scores, given the relatively short two-week dosing window. Prof. Eastwood is also the director of the Centre for Sleep Science, which is based at the University of Western Australia.
Although the clinical trial findings won’t be published until the end of March 2020, the Chairman of Zelira Osagie Imasogie said that the company can now commercialize ZLT-101 across the globe this year.
Patients who have chronic insomnia have challenges sleeping or staying asleep. They do not feel refreshed even after adequate sleep, and they also suffer from impairment during their day-to-day activities for a minimum of four weeks.
It is widely expected that other marijuana industry players, such as SinglePoint Inc. (OTCQB: SING), are happy that these research findings are positive since they add to the increasing body of evidence proving the therapeutic effects of marijuana on various health conditions.
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