Apnimed unveiled the full results of its MARIPOSA phase 2b trial, revealing that AD109, an investigational oral drug for obstructive sleep apnea (OSA), showed significant symptom improvement over the four-week period.
The results are published in the American Journal of Respiratory and Critical Care Medicine.
Additional data build on evidence supporting the efficacy, safety, and optimal dosing of AD109, a combination of aroxybutynin 2.5mg and atomoxetine 75mg, as it advances into phase 3 clinical trials. AD109 has the potential to be the first-in-class oral drug treatment for people with mild, moderate, and severe OSA, according to a release from Apnimed.
The published data reinforce findings from the placebo-controlled trial of 211 randomized patients that showed:
- AD109 demonstrated a clinically and statistically significant improvement in OSA over the four-week period in adults with mild to severe sleep apnea.
- The study met its primary endpoint, reduction in the apnea-hypopnea index (AHI4, 4% desaturation definition for hypopneas). AHI4 was reduced by 45% for patients treated with AD109 compared to placebo.
- In addition, the 2.5/75 mg dose of AD109 demonstrated statistically significant improvement on the PROMIS-Fatigue scale, which measures daytime fatigue and its impact on daily activities.
- AD109 was safe and well tolerated. There were no serious adverse events and no new or unexpected adverse events in the MARIPOSA trial. The most common adverse events in patients treated with AD109 were dry mouth, insomnia, and nausea.
“The standard of care for treating obstructive sleep apnea is CPAP, a mechanical device that is effective but not well tolerated by many OSA patients,” says Paula Schweitzer, PhD, lead author and an investigator in the MARIPOSA trial and director of research at St Luke’s Sleep Medicine and Research Center, in a release. “It’s time we have new treatment options that offer a different approach. I’m encouraged by the clinically significant improvement seen with AD109 in MARIPOSA, and I am excited to learn more about its therapeutic potential in the ongoing AD109 Phase 3 trials.”
Larry Miller, MD, CEO of Apnimed, adds in a release, “The MARIPOSA results provided the guidance necessary to proceed with our phase 3 program. The 2.5mg/75mg dose of AD109 was identified as the optimal dose that we will be taking forward.”
Based on consultation with the US Food and Drug Administration (FDA) earlier this year, Apnimed has initiated the recruitment phase of the first phase 3 trial of AD109, called LunAIRo. Prospective participants may evaluate their eligibility at SleepApneaTrial.com.
AD109 has been granted Fast Track designation by the FDA.