Therapix Biosciences Ltd, a specialty, clinical-stage pharmaceutical company focusing on the development of cannabinoid-based treatments, announced today topline results from its Phase IIa clinical study. The results suggest that THX-110, a combination of dronabinol (∆ -9-tetrahydracannabinol, THC) and CannAmide (palmitoylethanolamide, PEA), positively affects symptoms in adult subjects with obstructive sleep apnea (OSA).
The study was a single-arm, open-label trial, in which each subject received one daily treatment, each day for 30 days of THX-110 via oral administration and was followed-up for a period of 30 days. Ten subjects participated in the study and received THX-110 at Assuta Hashalom Medical Center in Israel. The primary endpoint of the study was to assess the performance of THX-110 in the treatment of adult patients suffering from OSA, as measured by the apnea-hypopnea index (AHI). This measurement evaluates quality of sleep before and after the treatment. Treatment was given in a dose titration regimen with a maximum dose of THX-110 consisting of 10mg dronabinol and 800 mg PEA.
The study was conducted under the leadership of Yaron Dagan, head of the Sleep Medicine Institute at Assuta, and principal investigator, Dr Lilach Kemer.
Of the 10 patients recruited into the study, 9 have completed the study and 1 has dropped out of the study due to treatment associated adverse event (dizziness). Among the remaining nine patients, 55% demonstrated significant improvement in AHI values (t-test; AHI mean difference 0.013, p