New studies: sleep apnea pill shows long-term effect and improved quality of life for mild to severe OSA


Sleep Disorders | Sleep Review

Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacological treatments for the treatment of obstructive sleep apnea (OSA) and related disorders, reports positive data on multiple endpoints from a randomized, double-blind, placebo-controlled Phase 2 Phase 2 -Study a factorial crossover clinical study with single dose (APC-003) and a 28-day open label extension study evaluating AD109 as a treatment in patients with mild to severe OSA.

AD109 is Apnimed’s oral pharmacological test combination, dosed once daily at bedtime, designed to treat OSA patients with a wide range of disease severity levels. AD109 targets key neurological pathways in OSA that cause pathological obstruction of the upper airways during sleep. AD109 combines a selective norepinephrine reuptake inhibitor (atomoxetine) with Apnimed’s novel new chemical substance – a selective antimuscarin (aroxybutynin).

The randomized, placebo-controlled portion of the study showed that after a single dose, AD109 had a statistically significant and clinically meaningful difference from placebo in patient hypoxic exposure (HB), the primary endpoint of the study. Hypoxic exposure is a measure of the total amount of hypoxemia associated with respiratory events or low blood oxygen during sleep. The Apnea-Hypopnea Index (AHI), which was a secondary endpoint indicating the number of apnea (cessation of breathing) and hypopnea (shallow breathing) events per hour of sleep, showed a similar reduction for AD109 compared to placebo. In addition, AD109 was shown to have sustained effects during the open label extension phase of this clinical trial when patients took AD109 for 28 days. Patients also experienced improvements in quality of life, nighttime breathing, and sleep in both objective and subjective measurements.

“Today we announced the results of two key studies with our lead program AD109 that examined two different patient populations with OSA and different efficacy parameters,” said Larry Miller, MD, CEO of Apnimed, in a press release. “Both studies demonstrate the potential of this oral pharmaceutical option to have a positive impact on patients who need safe and easy-to-use solutions to treat their disease. The results of the APC-003 study and its open label extension provide strong evidence of the persistence of the effect over 28 nights of treatment with AD109 and show improvements in the patient’s sleep quality in several key measures.

Importantly, the open label extension also looked at the effects of AD109 on the patient’s quality of life, using a gold standard score, the OSA-Specific Quality of Life Index (SAQLI), in which patients showed statistically significant improvements the quality reported of life suggesting a significant improvement in symptoms with chronic treatment. We look forward to confirming these results and those of the APC-004 study in our planned phase 2 clinical trial MARIPOSA, which will begin later this year. “

“The results from the APC-003 study are incredibly encouraging,” said James Maynard MD, lead investigator on the study at the CTI Clinical Research Center. “With AD109, we see a clinically meaningful improvement in oxygen delivery and breathing during sleep, as well as evidence that these measures improve over time, suggesting the potential for greater benefit the longer patients receive an oral treatment approach. “

Apnimed is also reporting results from a second Phase 2 study, APC-004, examining the safety and effectiveness of AD109 in patients with mild to moderate OSA.

This phase 2 randomized, double-blind, placebo-controlled, crossover clinical study shows positive data across multiple endpoints.

Patients treated with both the high and low doses of AD109 showed a large, statistically significant, and clinically meaningful difference in their hypoxic exposure versus placebo after a single dose. AHI, a secondary endpoint, showed a similar reduction at both high and low doses of AD109. Treatment with AD109 was safe and well tolerated in both doses tested.

“We are very encouraged by these results, which further reinforce the potential of AD109 to have a clinically meaningful benefit for patients with mild to moderate OSA,” says Miller. “Both doses investigated in this clinical study resulted in statistically significant improvements in multiple measurements of disease severity and showed clear indications of dose-response.

“These data, combined with those from our Phase 2 APC-003 study in a patient population with more severe disease, support the advancement of AD109 as the first pharmacological treatment for patients with varying degrees of OSA. We plan to initiate a third phase 2 confirmatory study called MARIPOSA to begin later this year. MARIPOSA will help us complete the study design and dosages for our Phase 3 program, which we expect to start at the end of 2022. “

Russell Rosenberg, MD, principal investigator of the study from Neurotrials Research, said in a press release, “Many OSA patients go untreated because the treatment options currently available can be inconvenient and cumbersome, and patients are at risk for potentially debilitating health consequences. These AD109 data are the first evidence of clinically meaningful benefit from a pharmacological approach to the treatment of OSA which, if successful, could revolutionize the way we treat this highly debilitating disease that is having a major impact on the health of the population affected persons. “

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