Medical Cannabis Company Zelira's Insomnia Drug Aces Midstage Trial

Australian medical cannabis company Zelira Therapeutics Ltd ZLDAF reported a positive Phase 1b/2a data readout Tuesday for a clinical trial evaluating its investigational cannabinoid therapy ZLT-101 for treating patients with chronic insomnia.

The study achieved the primary endpoint of a statistically significant improvement in Insomnia Severity Index scores in a trial that recruited 24 chronic insomnia patients ages 25-70, the company said. 

The enrolled patients were treated with 14 nights of ZTL-101 and, after a washout period of a week, with 14 nights of placebo. The participants were administered either a single dose or double dose of medication delivered sublingually, according to their symptoms.

ZLT-101 was found to be safe and well-tolerated, according to Zelira. 

"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," Zelira Chairman Osagie Imasogie said in a statement.

The company said it expects to release a final report from the clinical study, including a comprehensive suite of secondary endpoints, by the end of March. 

After remaining halted for trading since Feb. 14, the OTC-listed shares last exchanged hands at 4 cents, down 32.2%.

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Photo courtesy of Zelira Therapeutics.