CAMBRIDGE, Mass. (October 18, 2022)—Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies to treat obstructive sleep apnea (OSA) and related disorders, announced positive topline results from the MARIPOSA Phase 2b trial, an efficacy, safety and dose-finding study of one-month duration.
The topline results were positive for the company’s lead candidate for OSA, AD109 (atomoxetine + aroxybutynin). The primary endpoint showed a statistically significant reduction in the Apnea-Hypopnea Index (AHI, the standard measure of OSA severity and nighttime breathing) for both doses studied (p<0.001 vs. placebo). Results from the MARIPOSA trial also demonstrated that AD109 improved daytime symptoms caused by OSA and was safe and well-tolerated. Results from this study support dose and endpoint selection for Apnimed’s Phase 3 studies of AD109, anticipated to start in the first half of 2023, following discussions with the U.S. Food and Drug Administration (FDA).
“MARIPOSA results support the therapeutic potential of AD109 as a convenient, nightly treatment for OSA, which would represent a major breakthrough in the management of this serious disease,” said Paula Schweitzer, Ph.D., an investigator in the MARIPOSA trial and the director of research at St. Luke’s Sleep Medicine and Research Center in Chesterfield, Missouri. “Improved nighttime breathing and sleep, and improved daytime fatigue were observed, which have the potential to dramatically improve quality of life.”
Ron Farkas, M.D., Ph.D., Chief Medical Officer of Apnimed added, “MARIPOSA was a large study that we believe provides compelling evidence, along with earlier Apnimed studies, of AD109’s potential to improve the lives of people with OSA. We plan to request an End of Phase 2 meeting with FDA shortly to obtain further clarity on Phase 3 and our subsequent marketing application for AD109.”
MARIPOSA was a randomized, double-blind, placebo-controlled dose-finding study of one-month duration. A total of 294 participants with a wide range of OSA severity, from mild to severe (AHI4 of 10-45), were enrolled at 25 sites across the United States. Participants were randomized to parallel arms comparing two doses of AD109, two doses of AD504 (a second candidate in an earlier phase of development), atomoxetine alone and placebo. Enrollment was open both to treatment-naïve participants and to the substantial proportion of OSA patients who are unwilling or unable to tolerate treatment with positive airway pressure devices (e.g., CPAP), the current standard of care therapy for OSA.
MARIPOSA was also designed to incorporate other standard clinical endpoints designed to characterize improvement of oxygenation, sleep and daytime function in OSA.
It is one of the largest clinical trials ever conducted of promising drug candidates designed to target the underlying cause of OSA.
AD109 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA).
Apnimed plans to present additional findings and analyses at upcoming scientific conferences.
Learn more at apnimed.com.
