Zelira Therapeutics has reported positive data from the Phase Ia/IIb clinical trial of medicinal cannabis for the treatment of insomnia.
The trial, which was conducted at University of Western Australia (UWA) Centre for Sleep Science, met the primary and secondary endpoints.
During the study, the company’s cannabis formulation ZTL-101 was assessed for its efficacy in treating patients with chronic insomnia symptoms.
ZTL-101 was given to 23 participants for 14 nights and was followed by 14 nights of placebo. Each participant received 0.5ml of 11.5mg total cannabinoids or 1ml of 23mg total cannabinoid sublingually.
According to the trial data, the medication was well-tolerated without any serious adverse events.
Treatment with ZTL-101 was observed to be dose responsive, with a statistically significant decrease in ISI scores found with all doses compared to placebo.
The medication also led to an improvement in time spent asleep and sleep quality, as well as a decrease in wake time during the night.
Zelira Therapeutics chairman Osagie Imasogie said: “These positive results add ZLT-101to the portfolio of Zelira products being commercialised, including the recently launched HOPE range, in the US and globally, as a result of rigorous scientific work by the Zelira team.
“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. Zelira’s clinically validated products, such as ZLT-101, continue to play a disruptive role in the traditional pharmaceutical industry.”
The company plans to offer its medicinal cannabis for insomnia patients in countries where the medication is legalised, including the US, Germany, the UK and Australia.
It is expected that the launch in Australia will occur in the third quarter of this year.