Clinical-stage pharma company Apnimed has announced the dosing of the first patient in a Phase II clinical trial of its lead product candidate, AD109, for the treatment of mild to moderate Obstructive Sleep Apnea (OSA) and related disorders.
AD109 targets the neurologic control and aids in upper airway dilator muscle activation to maintain an open airway during sleep.
Dosed once-daily at bedtime, the investigational drug merges a selective norepinephrine reuptake inhibitor (NRI), atomoxetine, with a low dose NCE selective antimuscarinic, aroxybutynin.
OSA is a common and serious sleep disorder characterised by partial or full closure of upper airway while sleeping.
The randomised, double-blind, placebo-controlled, three-period, single-dose crossover factorial study will enrol 30 participants.
They will be given either two different dose levels of AD109 or placebo at bedtime across three overnight periods.
Apnimed CEO Larry Miller said: “In the fourth quarter of 2020, we initiated a Phase II study with our lead product candidate, AD109, in patients with a broad spectrum of OSA, from mild to severe.
“With this study we will explore the safety and effectiveness of several doses of AD109 in patients with milder disease, potentially expanding the population of patients we can help.”
Apnimed expects data from both these Phase II studies in the second quarter of this year. The company will then progress to Phase III registrational study.
The company showed Proof-of-concept for the AD109 programme in a Phase II parallel group dose-finding study of atomoxetine (aroxybutynin) plus racemic oxybutynin.
It showed evidence of safety and efficacy in OSA treatment with an NRI plus antimuscarinic in 140 patients. This signifies that a pharmacologic approach can potentially treat the underlying neurobiology of OSA, Apnimed noted.
In the Phase I study, aroxybutynin was demonstrated to be safe and well-tolerated, with a favourable pharmacokinetic profile, leading to Phase II studies of AD109.