AD109 for Obstructive Sleep Apnea

Enrolling by invitation at 101 trial locations

Overseen By Luigi Taranto, MD, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Apnimed

Disqualifiers: Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, AD109, for individuals with obstructive sleep apnea (OSA), a condition where breathing stops and starts during sleep. The goal is to determine if AD109 can improve symptoms by combining two drugs, aroxybutynin and atomoxetine. Eligibility is open to those who completed a previous related study without permanently stopping the treatment. Participants must not have any conditions or treatments that would make participation unsafe. As a Phase 3 trial, this is the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for OSA.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, the investigator will decide if your current medications make participation unsafe.

Is there any evidence suggesting that AD109 is likely to be safe for humans?

Research has shown that AD109, a combination of aroxybutynin and atomoxetine, is generally safe for individuals with obstructive sleep apnea (OSA). In one study, over 22% of participants using AD109 achieved complete control of their OSA, experiencing fewer than five breathing interruptions per hour during sleep. Another year-long study found AD109 to be both safe and effective for individuals with mild, moderate, and severe OSA.

Overall, these studies suggest that AD109 is safe for use. Participants in these trials did not report any major safety issues, and the treatment was well-received. As the treatment nears the final stages of testing, many potential safety concerns have already been addressed in earlier studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obstructive sleep apnea?

Unlike the standard treatments for obstructive sleep apnea, which often involve devices like CPAP machines or surgeries, AD109 offers a pill-based alternative. Researchers are excited about AD109 because it combines two active ingredients that target neurotransmitter pathways to keep the airway open during sleep. This approach could potentially simplify the management of sleep apnea, making it easier for patients to adhere to treatment and improving their quality of life.

What evidence suggests that AD109 might be an effective treatment for obstructive sleep apnea?

Research has shown promising results for the drug AD109 in treating obstructive sleep apnea (OSA). In one study, 51.2% of participants taking AD109 experienced a reduction in the severity of their OSA. Additionally, 22.9% of these participants achieved complete control of their OSA, with breathing interruptions dropping to less than 5 times per hour. In comparison, the placebo group saw only a 6.8% improvement. These results suggest that AD109 could significantly help manage OSA symptoms. ^{2 3 4 6 7}

Who Is on the Research Team?

Ron Farkas, MD

Principal Investigator

Apnimed

Are You a Good Fit for This Trial?

This trial is for individuals who have completed one of the parent Phase 3 studies, APC-APN-304 or APC-APN-305, and are diagnosed with obstructive sleep apnea (OSA). Specific eligibility details are not provided but typically include meeting certain health standards.

Inclusion Criteria

Completion of APC-APN-304 without permanent discontinuation of IMP

Completion of APC-APN-305 without permanent discontinuation of IMP

Exclusion Criteria

Participants are excluded from the study if participation would be considered unsafe by the investigator based on the individual's current status

Participants are excluded from the study if participation would be considered unsafe by the investigator based on concomitant therapies.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label Treatment

Participants receive the combination drug AD109 in an open-label format

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AD109

Trial Overview The study tests a combination drug called AD109, made up of aroxybutynin and atomoxetine. It's an open label continuation from previous double-blind studies aimed at treating OSA in those who've already participated.

How Is the Trial Designed?

Group I: AD109 Experimental Treatment 1 Intervention

Open Label AD109

Who Is Running the Clinical Trial?

Apnimed

Lead Sponsor

Trials

17

Recruited

3,400+

Citations

1. apnimed.com apnimed.com/article/apnimed-to-present-additional-phase-3-data-for-ad109-an-investigational-oral-pill-for-obstructive-sleep-apnea-at-chest-2025-annual-meeting/

Apnimed To Present Additional Phase 3 Data for AD109, ... 51.2% of participants treated with AD109 showed a reduction in OSA disease severity category; 22.3% of participants treated with AD109 achieved ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2451865425001127

Aroxybutynin and atomoxetine (AD109) for the treatment of ... We hypothesize that AD109 will significantly reduce AHI4 and symptomatic fatigue compared to placebo in people with OSA. The primary outcome for both trials is ...

3. aasm.org aasm.org/apnimed-second-clinical-trial-sleep-apnea-medication/

Apnimed announces results from second study of sleep ... In contrast, the AHI was reduced by only 6.8% in those who took a placebo. The reduction in AHI with AD109 remained significant after 51 weeks, ...

4. prnewswire.com prnewswire.com/news-releases/apnimed-to-present-additional-phase-3-data-for-ad109-an-investigational-oral-pill-for-obstructive-sleep-apnea-at-chest-2025-annual-meeting-302587042.html

Apnimed To Present Additional Phase 3 Data for AD109 ... 22.9% of participants treated with AD109 achieved complete OSA disease control (defined as AHI <5 events/hour); AD109 was generally well- ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10765395/

The Combination of Aroxybutynin and Atomoxetine in the ... That study reported a dose–response improvement in OSA severity with a single night of AD109 (aroxybutynin 2.5 mg combined with atomoxetine 37.5 or 75 mg) ...

6. apnimed.com apnimed.com/article/ad109toplinephase3results/

Apnimed Reports Positive Topline Results from Second ... LunAIRo was a 12-month study that evaluated the efficacy and safety of AD109 in adults with mild, moderate and severe OSA, across a wide range of weight ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04580394

Crossover Trial of AD109 in Obstructive Sleep Apnea This is a randomized, 4-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of AD109 versus its individual ...