Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies for the treatment of obstructive sleep apnea (OSA) and related disorders, presented positive results from the MARIPOSA phase 2b trial, an efficacy, safety, and dose-finding study of AD109 over a one-month duration, at the ATS 2023 International Conference.
On the trial’s primary endpoint of apnea-hypopnea index (AHI4, 4% desaturation definition for hypopneas), MARIPOSA showed that AD109 (aroxybutynin and atomoxetine) at both doses tested achieved a statistically significant reduction of AHI4 compared to placebo. Dosing with AD109 led to clinically important reductions in AHI in most patients with mild, moderate, and severe OSA.
MARIPOSA results also showed that AD109 improved daytime fatigue, “an often-debilitating effect of poor sleep due to OSA,” says Paula Schweitzer, PhD, an investigator in the MARIPOSA trial and the director of research at St. Luke’s Sleep Medicine and Research Center, in a release. “For those who cannot tolerate current treatments, AD109 has the potential to be a convenient, oral pill that could improve people’s quality of life both at night and during the day,” adds Schweitzer in the release.
The MARIPOSA results provided the guidance necessary to proceed with a phase 3 program, according to Larry Miller, MD, CEO of Apnimed, in a release, who notes the 2.5mg/75mg dose of AD109 was identified as the optimal dose that will be taken forward.
Based on consultation with the US Food and Drug Administration, Apnimed plans to begin two phase 3 registration trials in the second half of 2023.
AD109 has been granted Fast Track designation by the FDA.