Data from Apnimed’s MARIPOSA phase 2b trial—an efficacy, safety, and dose-finding study of one-month duration of its drug candidate for obstructive sleep apnea (OSA)—will be featured in an oral presentation and a poster presentation at The American Thoracic Society’s ATS 2023 International Conference in Washington, DC.
“ATS 2023 will be our first opportunity to present data from MARIPOSA, a study that found patients treated with the company’s lead candidate for OSA, AD109 (aroxybutynin and atomoxetine), had a statistically significant reduction in apnea-hypopnea index scores, improved daytime symptoms caused by OSA, and was well-tolerated,” says Larry Miller, MD, CEO of Apnimed, in a release. “These data support the dose and endpoint selection we have discussed with the US Food and Drug Administration for our phase 3 studies scheduled to start in the second half of 2023.”
Oral: Abstract 6336
Title: The Oral Agent AD109 Improves Objective and Subjective Outcomes in Obstructive Sleep Apnea Patients. Results from the MARIPOSA Study, a Randomized, Controlled Clinical Trial
Session: A18 – Breaking News in OSA: New Approaches and New Trials Mini-Symposium
Time: Sunday, May 21, 10 to 10:12 AM ET
Location: Walter E. Washington Convention Center, Room 202 B (Level 2)
Presenter: Paula Schweitzer, PhD, director of research at St. Luke’s Sleep Medicine and Research Center
Poster: Abstract 8755
Title: Comparison of Night-to-Night and Inter-scorer Variability of Different Indices of Obstructive Sleep Apnea Severity in the MARIPOSA Trial
Session: C110 – Advanced Signal Anaylsis: New Diagnostics and Physiologic Insights for SDB Poster Discussion Session
Time: Tuesday, May 23, 2:15 to 4:15 PM ET
Location: Walter E. Washington Convention Center, Room 144 A-C (Street Level)
Presenter: Huy Pho, Clinical Data Scientist, Apnimed
MARIPOSA was a randomized, double-blind, placebo-controlled dose-finding study encompassing of 294 participants with a range of OSA severity, from mild to severe, who 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 also incorporated other standard clinical endpoints designed to characterize improvement of oxygenation, sleep, and daytime function in OSA.
AD109 is designed to treat the underlying cause of OSA, airway obstruction at night, and improves daytime consequences of OSA, such as fatigue. AD109 targets key neurological pathways in OSA that activate upper airway dilator muscles to maintain an open airway during sleep. AD109 has been granted Fast Track designation by the FDA.