Shots:
- Apnimed has reported topline P-III (SynAIRgy) trial data assessing AD109 (aroxybutynin 2.5mg/atomoxetine 75mg) vs PBO for 6mos. in 646 adults with mild to sev. OSA across all weight classes who are intolerant of or refuse CPAP therapy
- Trial met its 1EP with a mean change in AHI at 26wks. & showed improvements across exploratory & 2EPs, incl. better oxygenation, with 51.2% & 22.3% of AD109 pts achieving reduced disease severity & complete disease control (AHI <5 events/hr.), respectively; data to be shared & published in future
- Additionally, Apnimed plans to submit an NDA for AD109 to the US FDA by early 2026, plus topline data from the 1yr. P-III (LunAIRo) trial for OSA is expected in Q3’25
Ref:Â Prnewswire |Â Image: Apnimed |Â Press Release
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