Advancing novel pharmacologic treatments for sleep disorders
|Program||Indication/ Formulation||Preclinical||Exploratory Clinical||Phase 1||Phase 2||Phase 3|
(atomoxetine + aroxybutynin)
(atomoxetine + oxybutynin)
(atomoxetine + trazodone)
|OSA w/disturbed sleep
Novel release profile
|Other Programs||Monotherapy or combination alternatives for OSA and snoring|
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Lead Product Candidate
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 is currently studied in the Phase 2 randomized, double-blind, parallel-arm MARIPOSA trial.
The AD109 program is supported by additional clinical data collected with AD036, which consists of the norepinephrine reuptake inhibitor atomoxetine, combined with the anti-muscarinic, racemic oxybutynin. That combination was studied in a large Phase 2 clinical trial that included 140 patients with a broad range of OSA severity from moderate to very severe. AD036 improved multiple objective measures of OSA as well as OSA symptoms, providing proof-of-concept that an oral pharmacologic approach may have clinical benefit in patients with OSA.
Lead Product Candidate
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.