Advancing novel pharmacologic treatments for sleep disorders
| Program | Indication | Discovery | Preclinical | Phase 1 | Phase 2 | Phase 3 | AD109 (aroxybutynin + atomoxetine) |
OSA |
|
|---|---|---|---|---|---|---|
| JV Programs | Other Sleep and Breathing Diseases |
Shionogi-Apnimed Sleep Science
|
The investigational product candidates on this page are not approved by the FDA and their safety and effectiveness have not been established.
The investigational product candidates on this page are not approved by the FDA and their safety and effectiveness have not been established.
The investigational product candidates on this page are not approved by the FDA and their safety and effectiveness have not been established.
learn about our studies
Lead Product Candidate
AD109
AD109 is a first-in-class, oral pharmaceutical combination dosed once-daily at bedtime, designed to treat OSA patients across a broad spectrum of disease severity. AD109 combines a novel NCE selective antimuscarinic, aroxybutynin, with a selective norepinephrine reuptake inhibitor (NRI), atomoxetine. In May 2022, the FDA designated AD109 for OSA as a Fast Track development program, which makes the program eligible for expedited review by the FDA.
We believe a novel, oral and convenient treatment option to treat the underlying cause of OSA could be positioned to capitalize on the significant unmet need. If approved, we believe AD109 has the potential to become the standard of care for the treatment of OSA.
We have conducted more than 15 Phase 1 and 2 clinical trials that inform various aspects of the AD109 program, and have amassed efficacy, safety and tolerability data for AD109 across multiple completed clinical trials in OSA. AD109 was studied in the Phase 2 randomized, double-blind, parallel-arm MARIPOSA trial. In MARIPOSA, AD109 met both the primary breathing endpoint (AHI reduction, p<0.0001) and secondary oxygenation endpoints (reduction of oxygen desaturation index (ODI) p<0.001 and hypoxic burden (HB) p<0.05) and demonstrated clinically meaningful and statistically significant improvement of the tertiary OSA symptom endpoint of fatigue (Patient-Reported Outcomes Measurement Information System (PROMIS)- Fatigue, p<0.05) at one month. MARIPOSA was designed to evaluate AD109 across a broad range of OSA severity, including mild, moderate and severe OSA and enrolled 211 patients in the United States. It is currently in Phase 3.
Next Generation Programs
Apnimed is also exploring additional product candidates designed to treat other sleep and breathing diseases. We intend to develop these additional proprietary product candidates independently by leveraging our in-house expertise across key functional areas of drug identification and development powered by a team with long-standing experience in sleep and breathing diseases, drug development and new product commercialization. Some of Apnimed’s next-generation programs are managed by Shionogi-Apnimed Sleep Science, a Joint Venture with Shionogi & Co., Ltd.