Four of the 7 patients exhibited significant improvement in all assessed study parameters, which included reduction in the Apnea-Hypopnea Index scale and an improvement in oxygen desaturation index, with 1 patient demonstrating mild improvement; overall THX-110 was generally well tolerated.
Ascher Shmulewitz, M.D., Ph.D., Chairman and interim CEO of Therapix
BAscher Shmulewitz, MD, PhD
Therapix Biosciences announced interim results from a phase 2a clinical study that suggest THX-110, a combination of dronabinol and palmitoylethanolamide (PEA), positively affects symptoms in adults with obstructive sleep apnea.
The interim results from the single-arm, open-label, proof-of-concept trial (NCT03646552) include data from the first 7 out of 30 patients who have completed the study per protocol and 1 patient who dropped out early due to dizziness. Four of the 7 patients exhibited significant improvement in all assessed study parameters, which included reduction in the Apnea-Hypopnea Index (AHI) scale and an improvement in oxygen desaturation index, with 1 patient demonstrating mild improvement. THX-110 was reported to be generally well tolerated, with only 2 patients exhibiting adverse effects, which were resolved after the THX dosage was decreased to 5 mg/day.1 Topline results are expected to be reported in the second half of 2019.
“We continue to be excited about that the synergistic effect of the THX-110 CannAmide entourage program,” Ascher Shmulewitz, MD, PhD, chairman, interim chief executive officer, Therapix, said in a statement.1 “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.”
The trial aims to confirm the safety, tolerance, and efficacy of THX-110, and to assess its performance in adults with obstructive sleep apnea. Study participants are slowly titrated on a once daily, oral THX-101 dose during the first 10 days of the study to 2.5 mg for 3 days, 5 mg for 3 days, 7.5 mg for 3 days, and increasing to 10 mg for the remainder of the trial; PEA will be given in a constant dose of 800 mg per day concomitantly for the entire study duration. The intervention will only be increased if the subject is tolerating the previous dose and can be reduced based on adverse effects. Patients are followed for a total of 30 days.
The primary efficacy endpoint is evaluating the significant change in the AHI, while the secondary outcome measure includes the change in oxygen desaturation index. Safety outcomes include the measurement of serious adverse effects, and the number of adverse effects, anticipated and unanticipated.
“The results are encouraging,” Professor Yaron Dagan, head of the Sleep Medicine Institute, Assuta, said in a statement. “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 obstructive sleep apnea patients with a pharmacological approach could dramatically improve the patient experience and likelihood of adherence.”
The THX-110 program uses a unique approach to cannabinoid formulation through a “Entourage Effect” hypothesis in which the endocannabinoid system acts synergistically to modulate the overall psychoactive effects. According to Therapix, the benefits of the PEA combination are considered to increase in efficiency of oral administration, which enables a decrease in dosage, and lowering of adverse effects.2
In addition to obstructive sleep apnea, THX-110 is also currently being studied in chronic pain and Tourette syndrome, for which top-line results from the phase 2b trial are expected in the second half of 2020.
1.Therapix Biosciences Announces Interim Results of Phase IIa Study at Assuta Medical Center for Obstructive Sleep Apnea Program [news release.] Tel Aviv, Israel: Therapix Biosciences; June 18, 2019. https://finance.yahoo.com/news/therapix-biosciences-announces-interim-results-133000134.html. Accessed June 20, 2019.
2. Research and Development. Therapix. https://therapixbio.com/the-entourage-effect/.