Therapix Biosciences has enrolled the first patient in a Phase IIa trial evaluating THX-110 for the treatment of Obstructive Sleep Apnea (OSA) at Assuta Medical Center in Israel.
Entitled ‘Examining the Efficacy of a Therapeutic Combination of Dronabinol (Pharma-grade ∆9-tetrahydracannabinol) and Palmitoylethanolamide (PEA) for Obstructive Sleep Apnea’, the trial is a single-arm, open-label study.
The proof-of-concept trial is being conducted under the leadership of Assuta Medical Center Sleep Medicine Institute head Yaron Dagan. Dr Lilach Kemeris is the principal investigator of the trial, which aims to enrol 30 patients.
The trial aims to confirm the safety, tolerance and efficacy of THX-110, and to assess its performance in adult patients suffering from symptoms of OSA.
During the trial, the enrolled patients will receive one daily treatment of THX-110 via oral administration and is followed up for one month.
Primary efficacy endpoint of the trial is the analysis of a significant change in the apnea-hypopnea index (AHI), which refers to the severity of sleep apnea as measured during a sleep test.
Therapix Biosciences chief technology officer Adi Zuloff-Shani said: “The initiation of this study represents a significant milestone for Therapix Biosciences as it marks the start of the company's third clinical programme.
“We believe that our rapid progress, from receiving the Israeli Ministry of Health and Ethics committee clearance to initiating patients' enrolment, is indicative of the expertise of our internal team, as well as the relationships we've built with our investigator partners.”
According to the American Academy of Sleep Medicine (AASM), 12% of the adult population in the US is estimated to suffer from OSA, and the annual economic burden of undiagnosed sleep apnea in the country is nearly $150bn.
Therapix’ THX-110 features a cannabinoid-based technology and has the potential to treat OSA.