Advancing novel pharmacologic treatments for sleep disorders
| Program | Indication/ Formulation | Discovery | Preclinical | Exploratory Clinical | Phase 1 | Phase 2 | Phase 3 |
|---|---|---|---|---|---|---|---|
| AD109 (aroxybutynin + atomoxetine) |
OSA |
|
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| AD504 | OSA w/disturbed sleep | ||||||
| Other Apnimed Clinical Programs | Monotherapy or combination alternatives for OSA and snoring | ||||||
| JV Clinical Programs | OSA subtypes |
Shionogi-Apnimed Sleep Science
|
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| JV Novel Chemistry and Targets | OSA subtypes |
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. The investigational drug is designed to be safe, effective, and convenient, addressing the key limitations of the current standard of care treatments.
If successful, this pharmacologic approach could substantially change the treatment of patients with disease severity ranging from symptomatic snoring through a substantial proportion of patients with severe OSA.
AD109 has successfully completed early-stage clinical trials. In a Phase 2, randomized, double-blind, single-dose trial of patients with mild through severe OSA, AD109 had a statistically significant and clinically meaningful difference from placebo in the patients’ Hypoxic Burden (HB), which was the study’s primary endpoint. HB is a measure of the total amount of respiratory event-related hypoxemia, or low blood oxygen during sleep. Additionally, during the open-label extension phase of this clinical trial, AD109 was shown to have a durability-of-effect when patients took AD109 for 28 days. Patients also experienced improvements in quality of life and sleep across both objective and subjective measures. AD109 also showed objective efficacy in a randomized, double-blind, single-dose Phase 2 study focused on mild-to-moderate OSA, at two different doses. AD109 was studied in the Phase 2 randomized, double-blind, parallel-arm MARIPOSA trial. It is currently in Phase 3.
AD504
Apnimed is developing AD504, a combination designed for OSA patients with symptoms of disturbed sleep. Phase 2 development of AD504 is incorporated in the MARIPOSA study.
AD504
Next Generation Programs
Apnimed is also developing other next-generation pharmacologic approaches for the treatment of OSA and related disorders based on cutting edge neurobiologic discoveries of the pathophysiology of OSA. Some of Apnimed’s next-generation programs are managed by Shionogi-Apnimed Sleep Science, a Joint Venture with Shionogi & Co., Ltd.