Australia-based Zelira Therapeutics has reported positive results from the Phase Ib/IIa clinical trial of cannabis drug candidate ZLT-101 in patients with chronic insomnia.
The randomised, double-blind, cross-over trial enrolled a total of 24 patients whose treatment regimen involved 14 nights of ZTL-101 followed by a one-week washout period and then 14 nights of placebo.
Before starting the dosing regimen, all patients were subjected to a sensitivity test to a mixture of ZTL-101 and placebo.
During the dosing period, each subject was given 0.5ml of 11.5mg total cannabinoids (single) or 1ml of 23mg total cannabinoids (double) dose of ZTL-101, based on their symptoms.
Of the total participants, 23 completed the trial. A total of 12 patients opted to increase the drug dose from a single to double dose.
The primary endpoints were safety and insomnia symptoms, determined using the Insomnia Severity Index (ISI ), at the end of each of the 14-night active drug or placebo periods. ZTL-101 met both the primary endpoints.
Data showed that the medication possibly caused 36 non-serious adverse events in 17 patients. The most frequent adverse events were xerostomia, dizziness, headache and feeling unwell.
With placebo, four participants had a total of four non-serious adverse events, with headache being the most frequent event.
In addition, a significant reduction in ISI scores from baseline was found after treatment with ZTL-101 compared to placebo.
Zelira Therapeutics chairman Osagie Imasogie said: “The positive outcome to this trial represents an important milestone for Zelira and its commitment to address the unmet need for clinically validated cannabis medicines and offer more treatment options to physicians and patients.
“Having successfully completed its recent merger, Zelira is now poised to rapidly commercialise the world’s first clinically validated cannabis medicine for insomnia into global markets in 2020, including the US, based on the positive results of this study.”
Final data from the study is expected to be available next month and is set to help design any future trials.
The company also intends to implement its strategy to supply the medication in markets where medicinal cannabis is legalised, such as Australia, the US, UK and Germany.