Advancing novel pharmacologic treatments for sleep disorders

Program Indication/ Formulation Preclinical Exploratory Clinical Phase 1 Phase 2 Phase 3
AD109
(atomoxetine + aroxybutynin)
OSA
Snoring
AD036
(atomoxetine + oxybutynin)
OSA
AD504
(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

AD109

Apnimed’s lead product candidate, AD109, targets key neurological pathways in OSA, reducing pathological upper airway closure during sleep. 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 selective norepinephrine reuptake inhibitor (NRI), atomoxetine, with a novel NCE selective antimuscarinic, aroxybutynin. 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 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

AD109

AD504

Apnimed is developing AD504, a combination of atomoxetine with a proprietary release profile and trazodone designed for OSA patients with symptoms of disturbed sleep. Phase 2 development of AD504 is incorporated in the MARIPOSA study.

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.

Next Generation Programs