Biopharmaceutical company Zelira Therapeutics (ASX: ZLD) has announced positive results from a “first of its kind” phase 1b/2a trial using medicinal cannabis to treat chronic insomnia.
The results confirmed all 23 participants treated with Zelira’s proprietary and patented medicinal cannabis formulation ZLT-101 demonstrated “statistically significant improvement” in Insomnia Severity Index (ISI) scores compared to the placebo.
In addition, the study showed that ZLT-101 therapy was safe and well tolerated, with no serious adverse effects reported.
Zelira managing director Dr Richard Hopkins told media in a teleconference today that achieving both of these primary endpoints is a “terrific outcome” and a “major milestone” for the company.
“The results cement our global leadership position in the medicinal cannabis biotechnology field and deliver on our commitment to address the unmet need for clinically validated cannabis medicines and offer more treatment options for physicians and patients,” he said.
According to Dr Hopkins, the trial’s outcomes also position the company to launch the world’s first clinically validated cannabis medicine for insomnia into global markets in 2020, including the United States – the world’s largest market for insomnia drugs.
“There is an estimated 70 million Americans suffering from insomnia today. The market for prescription and over-the-counter medication used to treat the condition in the US generates more than $2 billion in annual revenue, so it’s a substantial market that we’re going for,” he said.
Rigorous clinical trial
The study involved administering ZTL-101, an extract containing tetrahydrocannabinol (THC), cannabidiol (CBD) and cannabinol (CBN), to chronic insomnia patients for 14 nights, and 14 nights with a placebo, separated by a one-week washout period.
Each participant was able to take a single dose (0.5ml of 11.5mg total cannabinoids) or double dose (1ml of 23mg total cannabinoids) of the sublingual (delivered under the tongue) medication, according to their symptoms.
More than half of the participants chose to increase the ZTL-101 medication from a single to double dose, and 69.5% of patients were taking a double dose of the placebo on the 14th night.
A total of 36 non-serious adverse effects were recorded from 17 participants when taking ZTL-101, including xerostomia (dry mouth), dizziness, headache and feeling abnormal, compared to four non-serious adverse effects recorded from four participants during the placebo dosing.
All adverse effects were classified as mild and had typically resolved overnight or after waking.
The principal investigator for the study, Professor Peter Eastwood from the University of WA’s Centre for Sleep Science, said the study was “the most rigorous clinical trial ever undertaken to assess the therapeutic potential of medicinal cannabis to treat the symptoms of chronic insomnia”.
“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,” Professor Eastwood said.
Dr Hopkins said these outcomes suggest Zelira has “a lot of upside in terms of improving this efficacy read-out” if the dosing and treatment window the drug is further optimised.
“Additional analyses of the trial results are ongoing and we expect to release a final report, including data from a comprehensive suite of secondary endpoints, by the end of March 2020,” he said.
Completed merger and name change
Formerly Zelda Therapeutics, Zelira officially changed its name following a completed merger with US-based Ilera Therapeutics, which Dr Hopkins described as a “transformational” move.
“We have now formed a company with a world-leading pipeline of clinical candidates and also revenue-generating products, which can access the fastest growing and largest cannabis markets in the world.”
“I think the outcome we’ve seen today from the insomnia trial will highlight just how powerful that position will be in terms of our competitive landscape,” he said.
In early February, Zelira announced it had received commitments to raise nearly $4.59 million via a placement to sophisticated investors of 91.77 million fully paid shares at $0.05 each.
Earlier this week, the company advised it has accepted additional applications from overseas investors to raise a further $54,259. Following the acceptance of the over-subscriptions, the placement will raise $4.64 million (before costs).
The funds are intended to fast-track Zelira’s plans to launch multiple products into global markets in 2020 and to advance its clinical programs.
The shares will be issued under the company’s existing 15% placement capacity and accordingly, will not require shareholder approval.