US-based Apnimed has dosed the first subject in the multi-centre Phase IIA RESTEADY trial of SASS-001, an oral drug combo for sleep apnoea with a central component.
SASS-001 is a combination of selective P2X3 receptor antagonist, sivopixant, and another compound.
The randomised, controlled, dose-escalation, double-blind, parallel-arm trial is intended for underserved individuals with this condition.
It aims to enrol about 60 subjects at up to ten clinical sites in the US.
Subjects are set to be randomised to a dose-escalating arm of the therapy or a placebo arm.
They will take part in the trial for a ten-week period, with study measures including sleep-clinic polysomnography as well as at-home sleep assessments.
SASS-001 comes from Apnimed’s joint venture (JV) with Shionogi, named Shionogi-Apnimed Sleep Science (SASS), as its first clinical-stage asset.
The JV aims at expediting the discovery, preclinical and clinical development of pharmacologic solutions for addressing the pathology of sleep apnoea and other sleep-related conditions.
Apnimed CEO Larry Miller said: “With the first patient dosed in the Phase IIA RESTEADY trial, both Apnimed and SASS have reached an important milestone – the advancement of a scientific hypothesis to clinical development.
“Today’s announcement represents the combined efforts of the Apnimed and Shionogi teams, highlighting their respective strengths in sleep medicine drug development and drug discovery.”
In parallel, AD109, the company’s clinical programme, is advancing after the enrolment conclusion in its Phase III trials, LunAIRo and SynAIRgy, with these trials’ top-line data expected in the second and third quarters of this year, respectively.
AD109 is under evaluation in obese and non-obese adults with mild, moderate, and severe obstructive sleep apnoea (OSA).
In May 2023, the company reported positive outcomes from the MARIPOSA Phase IIb trial of AD109 for the treatment of OSA.
