Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic treatments to address obstructive sleep apnea (OSA) and related disorders, announced the dosing of the first patient in a study of the company’s lead investigational oral medication for the treatment of OSA.
“There are no approved drugs for the more than 25 million people in the US who have OSA, a common and serious sleep disorder in which breathing is repeatedly interrupted during sleep and that can have life-threatening consequences,” says Larry Miller, MD, chief executive officer of Apnimed, in a release. “The vast majority of diagnosed patients are prescribed positive airway pressure devices (for example, CPAP) but fewer than half are compliant long-term, leaving them at risk. With the MARIPOSA study underway, we are one step closer to bringing patients a potential new oral treatment option for OSA.”
MARIPOSA is a randomized, double-blind, placebo-controlled, parallel-arm, dose-finding one-month study designed to inform the Phase 3 dose for the oral medication AD109 and advance dose-finding for AD504 in participants (n=280) with mild, moderate, and severe OSA.
Patients will be randomized to parallel treatment arms comparing two doses of AD109, two doses of AD504, atomoxetine alone, and placebo.
The study’s primary endpoint measures the change in apnea hypopnea Index (AHI) over one month for AD109 versus placebo. Other endpoints include the change in AHI over one month for AD504, hypoxic burden (HB), a recently developed measure of the total amount of respiratory event-related hypoxemia, as well as several symptom scales.