Therapix Biosciences Ltd, a specialty, clinical-stage pharmaceutical company focusing on the development of cannabinoid-based treatments, released interim results from its Phase IIa clinical study at Assuta Medical Center in Israel. The results suggest that THX-110, a combination of dronabinol (?-9-tetrahydracannabinol) and CannAmide (palmitoylethanolamide, or PEA), positively affects symptoms in adult subjects with obstructive sleep apnea (OSA). The study is being conducted under the leadership of Yaron Dagan, MD, MSc, head of the Sleep Medicine Institute at Assuta, and principal investigator, Dr Lilach Kemer.
This Phase IIa clinical study is an open label study, which includes 30 patients diagnosed with OSA, to evaluate the safety, tolerability, and efficacy of once daily oral administration of THX-110. The interim report summarizes the data from the first 7 patients which completed the study per protocol and one patient who dropped out from the study early due to adverse events (dizziness). Out of the 7 patients who completed the study, 4 patients exhibited significant improvement in all assessed study parameters, including reduction in apnea-hypopnea index (AHI) scale and an improvement in oxygen desaturation index (ODI), with one patient showing mild improvement. In general, the study medication was well tolerated, with only two patients exhibiting negative results. Adverse events were resolved after THC dosage was decreased to 5 mg/day.
“The encouraging interim results of this study is a promising indicator that Therapix’s proprietary drug candidate THX-110 may provide a pharmacological treatment for OSA for which currently the only available standard treatments employ noninvasive ventilation devices (CPAP) and oral appliances,” says Adi Zuloff-Shani, PhD, chief technology officer at Therapix, in a release. “We are looking forward to the topline results, anticipated in the second half of 2019. Based on these encouraging interim study results, we intend to initiate a randomized, double-blind, placebo controlled study to evaluate the safety, tolerability and efficacy of daily oral THX-110 in treating adults with OSA.”
Dagan says, “The results are encouraging. Although too small to reach any conclusion, the magnitude of the effect is impressive, and suggests that a larger study is justified. The opportunity to treat the majority of OSA patients with a pharmacological approach could dramatically improve the patient experience and the likelihood of adherence.”
“We continue to be excited about that the synergistic effect of the THX-110 CannAmide entourage program,” says Ascher Shmulewitz, MD, PhD, chairman and interim CEO of Therapix. “These data are a catalyst for the acceleration of Therapix’s intent to continue, and even accelerate our clinical programs. In Europe, we intend in the second half of 2019 to introduce our botanical program for THX-110.”