Apnimed looks forward to Phase 3 studies
By HME News Staff
Updated 9:56 AM CDT, Mon October 17, 2022
CAMBRIDGE, Mass. – Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies to treat obstructive sleep apnea (OSA) and related disorders, has announced positive topline results from the MARIPOSA Phase 2b trial – an efficacy, safety and dose-finding study of one-month duration. The 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.
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