Secondary endpoints and final results from the clinical study will be announced at the end of March 2020.
Zelira Therapeutics announced that the results of its phase 1b/2a trial of ZLT-101, a cannabis-based investigational therapy, are positive, having the met primary end point in patients diagnosed with chronic insomnia.
Treatment with the therapy was associated with a statistically significant improvement in Insomnia Severity Index (ISI) scores. All told, there was a significant decrease in ISI following ZTL-101 (12.9 ±5.3; P <.001), but not following placebo (18.0 ±4.3; P >.05), compared with baseline (18.0 ±3.7). The magnitude of decrease in ISI scores was 5.2 ±4.3 (95% CI, 3.4 to 7.0), compared to 0.0 ±3.3 (95% CI, -1.8 to 1.9) with placebo.
"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. 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,” said Peter Eastwood, principal investigator of the study, and director, Center for Sleep Science at the University of Western Australia, in a statement.
The randomized, double-blind, cross-over design study evaluated 23 participants between 25 and 70 years of age. Patients received ZTL-101 for 14 nights and placebo for 14 nights, with a 1-week washout period separating the 2 doses. Prior to dosing commencement, each patient underwent a monitored sensitivity test to a mixture of ZTL-101 and placebo. Upon dosing, each patient had the option to take a single (0.5 ml of 11.5 mg total cannabinoids) or double (1 ml of 23 mg total cannabinoids) dose of medication.
Single dose medications of ZTL-101 were chosen by 12 of the 23 participants. At the 2 week-mark, 16 of the 23 (69.5%) of participants were taking a double dose of the placebo.
Investigators used the safety of the medication based on adverse event (AE) reporting and insomnia symptoms as measured by the ISI at the end of each of the 14-night active medication/ placebo periods as primary end points.
In total, there was 36 non-serious AEs likely related to ZTL-101 medication across 17 of the 23 patients. Xerostomia was among the most common AEs, occurring in 22.2% of cases, followed by dizziness, which occurred in 16.7% of all events. Other AEs included headache (11.1%) and feeling abnormal (11.1%).
Dosing of the placebo medication resulted in 4 non-serious AEs from 4 patients. Among those AEs were headache (50%), dizziness (25%) and variable mood (25%).
“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,” Osagie Imasogie, chairman of Zelira, said in a statement.
The company plans to announce results from the final report, which will include a comprehensive suite of secondary end points, by the end of March 2020.
Zelira Therapeutics meets primary endpoints for phase (1b/2a) medicinal cannabis trial for insomnia [news release]. Perth, Australia: Zelira Therapeutics. prnewswire.com/news-releases/zelira-therapeutics-meets-primary-endpoints-for-phase-1b2a-medicinal-cannabis-trial-for-insomnia-301007137.html. Accessed date February 19, 2020.