Therapix Biosciences has announced that investigational drug THX-110 yielded favourable data in a Phase IIa clinical trial involving adults with obstructive sleep apnea (OSA).
THX-110 is a combination of dronabinol (∆ -9-tetrahydracannabinol/THC) and CannAmide (palmitoylethanolamide/PEA).
The single-arm, open-label Phase IIa trial studied a once-daily, oral dose of the drug in ten patients at Assuta Hashalom Medical Center in Israel. The 30-day study involved a follow-up of an additional 30 days.
Participants received a dose titration regimen and the maximum dose was 10mg dronabinol and 800mg PEA.
Primary endpoint of the trial was the efficacy of THX-110 in adult patients. It was determined using the Apnea-Hypopnea Index (AHI), which measures OSA severity by assessing quality of sleep before and after treatment.
One participant discontinued the trial because of a treatment-related adverse event.
Of the remaining nine, 55% experienced significant improvement in AHI values, demonstrating a decrease of approximately 54% from baseline.
THX-110 was generally well tolerated, without any serious adverse events. Two patients had mild side effects, which were resolved after the THC dosages were decreased to 5mg/day.
Therapix Biosciences chairman and interim CEO Ascher Shmulewitz said: “Though initially the study was planned to include more subjects, the encouraging tendency of the results led us to the decision to reduce the study sample size and finalise the study in order to move to the next stage of this programme.”
The company focuses on the development of cannabinoid-based pharmaceuticals. In addition to OSA, THX-110 is being developed to treat Tourette syndrome (TS) and pain.
Therapix’s portfolio also includes THX-160 to treat pain and a drug programme for patients with epilepsy and inflammatory disorders.