Clinical Programs

Therapix expects to have results of Tourette's drug trial by end of first quarter

TEL AVIV (Reuters) - Israel’s Therapix Biosciences said on Monday it expects by the end of March to have the results from its mid-stage trial of a cannabinoid-based drug for treating Tourette’s syndrome which could be worth billions of dollars in revenues.

It has completed enrolment of 16 patients for its Phase IIa study at Yale University, where it will assess the drug that combines a synthetic cannabinoid already approved by the U.S. Food and Drug Administration with a fatty acid derivative called palmitoylethanolamide (PEA).

Therapix believes PEA may increase the efficacy of the cannabinoid while lowering the required dosage and reducing adverse effects.

Subjects in the 12-week study will receive a once-daily oral treatment with the objective of proving its safety, tolerability and efficacy in treating tics in adults with Tourette‘s, a neurological disorder characterized by repetitive, involuntary movements and vocalizations.

A Phase IIb placebo-controlled trial will start in the second quarter at Hanover Medical School and take about a year.

“We estimate the opportunity in Tourette’s to be about $1.5 billion in the United States,” Chief Financial Officer Josh Blacher told Reuters.

There are three FDA-approved drugs for Tourette‘s, all categorised as antipsychotics.

Chief Technology Officer Adi Zullof-Shani said around 200,000 U.S. patients have the condition and twice that number suffer from acute tic disorder.

Therapix, which listed on Nasdaq in March, is also testing the compound to treat sleep apnea, a $150-billion market worldwide.

Chief Executive Ascher Shmulewitz said FDA approval for both indications is not expected before 2020.

“We are looking to partner on some of these programs. We are in discussions with multiple companies,” he said, adding he expects to have news on this in 2018 as Therapix nears advanced phase III trials.

Potential partners could include other Nasdaq-listed companies developing cannabinoid-based drugs such as Britain’s GW Pharmaceuticals, the largest player in the sector, as well as Insys Therapeutics, Corbus Pharmaceuticals and Zynerba Pharmaceuticals.

There are also dozens of medical marijuana firms developing plant-based treatments. “They raised a lot of money and are looking for what to do with their money,” Shmulewitz said.

Editing by Greg Mahlich