PERTH, Australia – Medicinal cannabis company Zelira Therapeutics Ltd. reported that its ZLT-101 therapy met the primary endpoint of a statistically significant improvement in insomnia in a phase Ib/IIa study in patients diagnosed with chronic insomnia.
Zelira plans to launch the full-spectrum cannabis extract next month in countries and states where medicinal cannabis has been legalized, including Australia, the U.S., Germany and the U.K., said Richard Hopkins, managing director of ex-U.S. markets during a Feb. 19, 2020, conference call with analysts.
“The positive results represent an important milestone for Zelira and cements our global leadership position in the medicinal cannabis biotechnology field and delivers on our commitment to address the unmet needs of clinically validated cannabis medicines and offer more treatment options to physicians and patients,” Hopkins told analysts.
Perth, Australia-based Zelda Therapeutics Ltd. merged with U.S.-based Ilera Therapeutics Inc. in December 2019 to create Zelira Therapeutics, a global integrated biotech focused on clinical development of cannabis medical products that will be clinically validated. The merger brings together a pipeline of revenue-generating medicines and clinical candidates set to launch in 2020.
The insomnia trial recruited 24 patients with chronic insomnia between the ages of 25 to 70. The randomized, double-blinded, crossover study involved 14 nights of ZTL-101 and 14 nights of placebo, separated by a one-week washout period.
All participants underwent a monitored sensitivity test to a mixture of ZTL-101 and placebo prior to commencing dosing. When dosing commenced, each participant was able to take a single (0.5 ml of 11.5 mg total cannabinoids) or double (1 ml of 23 mg total cannabinoids) dose of the medication, delivered sublingually, according to their symptoms.
Of the 23 participants who completed the protocol, 12 (52%) chose to increase the ZTL-101 medication from a single dose to a double dose, and 16 participants (69.5%) were taking a double dose of the placebo on the 14th night.
Primary endpoints met
The primary study endpoints were safety of the medication based on adverse event reporting and insomnia symptoms as measured by the Insomnia Severity Index (ISI) at the end of each of the 14-night active medication periods.
A total of 36 non-serious adverse events were recorded from 17 participants. The most frequently reported adverse event was dry mouth (22.2% of all events) followed by dizziness (16.7%), headache (11.1%) and feeling abnormal (11.1%).
Four non-serious adverse events were recorded from four participants on the placebo medication. Headache was most frequently reported (50%) followed by dizziness (25%) and variable mood (25%).
All adverse events were classified as mild and had either resolved (97.5%) overnight or soon after waking.
Compared to baseline ISI scores (18.0±3.7), a significant decrease was observed following ZTL-101 (12.9±5.3, p0.05). The magnitude of decrease in ISI scores following ZTL-101 and placebo were 5.2±4.3 and 0.0±3.3, respectively. The ISI scores following ZTL-101 and placebo were significantly different (p<0.001).
“This study represents the most rigorous clinical trial ever undertaken to assess the therapeutic potential of medicinal cannabis to treat the symptoms of chronic insomnia,” said Peter Eastwood, principal investigator for the study, and director at the Centre for Sleep Science at the University of Western Australia.
“It’s also the first trial to use the Insomnia Severity Index, arguably the current gold standard in this field to measure the efficacy of a medicinal cannabis product to treat insomnia symptoms. The fact that ZLT-101 treatment achieved a statistically significant improvement in ISI scores is very impressive, particularly given the relatively short two-week dosing window.
“The lack of serious adverse or persistent mild adverse events is also encouraging given the reported safety issues for several already approved insomnia therapies. Taken together, these results suggest ZLT-101 has potential as a novel treatment for insomnia,” Eastwood said.
Hopkins said that additional analyses of secondary endpoints is ongoing, and the company will release a final report by the end of March 2020.
“The secondary endpoints will provide a breakdown on the quality of sleep, length of sleep, how people felt the next day and a raft of other quantitative measures that will show us how our therapy sits alongside other therapies,” Hopkins said.
“Having successfully completed its recent merger, Zelira is now poised to rapidly commercialize the world’s first clinically validated cannabis medicine for insomnia into global markets in 2020,” said Chairman Osagie Imasogie, who also serves as managing director in the U.S.
Imasogie said it was important to run a rigorous clinical trial that met the gold standard for pharmaceutical drugs.
“It was a bold move from our side, but it’s a move that comes from our pedigree of being pharma executives and in our confidence that this series of molecules of cannabis provide an opportunity to create new drugs derived from a natural product and to take these drugs through rigorous review and get them out to the marketplace.
“Zelira will continue to deploy its unique launch, learn and develop strategy to launch more scientifically validated products, targeting various conditions into the market in 2020.”
The company’s launch, learn and develop strategy boasts an accelerated path to market by launching products in the U.S., learning about them through patient interactions and then clinically validating them in Australia. It is expected to accelerate the commercialization process while generating revenue at the launch phase.
Zelira is also running trials in anxiety and opioid reduction. A phase I opioid reduction trial is being conducted at St. Vincent’s Hospital in Western Australia. An observational trial at the Children’s Hospital in Philadelphia is being conducted in autism, which relates to anxiety.
With a market cap of AU$51 million (US$33.8 million), Zelira’s shares remained flat on the trial news, trading on Australia’s Securities Exchange (ASX:ZLD) at AU5 cents by market close on Feb. 17.