aroxybutynin/atomoxetine (AD109) / Apnimed - LARVOL DELTA

Rationale and Design of a Phase 3 Open-label Extension Study of Fixed Dose Combination of Aroxybutynin and Atomoxetine (AD109) in Obstructive Sleep Apnea (ATS 2025) - P3 | "This large OLE study is designed to confirm and extend the safety evidence of the phase 3 SynAIRgy and LunAIRo randomized control trials evaluating the efficacy and safety of AD109 in the treatment of OSA. We have observed substantial participation and adoption for multiple-night use of digital tools including pulse oximetry and PROs to characterize both objective and subjective OSA burden. Data collected to date supports the long-term safety of AD109"

Clinical • P3 data • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Aroxybutynin and Atomoxetine (AD109) in Obstructive Sleep Apnea: Participant Demographics and Baseline Disease Characteristics of the Lunairo Phase 3 Trial (ATS 2025) - P3 | "Participants randomized in LunAIRo exhibit baseline AHI4 scores across the broad spectrum of OSA disease severity. The racial and ethnic diversity along with balanced ratio of female-to-male participants is representative of the general population of people living with OSA. Similarly, the symptom profiles reflect a typical sleep clinical referral population."

P3 data • Fatigue • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Apnimed's most advanced clinical program, AD109 (PRNewswire) - "Apnimed's most advanced clinical program, AD109, also continues to progress following the conclusion of enrollment in both Phase 3 clinical trials, LunAIRo and SynAIRgy. The Company continues to anticipate the availability of top-line data from both trials in Q2 and Q3 2025, respectively."

P3 data: top line • Trial status • Obstructive Sleep Apnea

Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study) (clinicaltrials.gov) - P3 | N=646 | Completed | Sponsor: Apnimed | Active, not recruiting ➔ Completed

Trial completion • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

APC-APN-201: Study That Tests AD109 in Patients Taking GLP-1 Drugs (clinicaltrials.gov) - P2 | N=40 | Completed | Sponsor: Apnimed | Active, not recruiting ➔ Completed

Trial completion • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

APC-APN-201: Study That Tests AD109 in Patients Taking GLP-1 Drugs (clinicaltrials.gov) - P2 | N=40 | Active, not recruiting | Sponsor: Apnimed | Recruiting ➔ Active, not recruiting | Trial primary completion date: Sep 2024 ➔ Dec 2024

Enrollment closed • Trial primary completion date • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

APC-APN-306: Continuation Protocol for Obstructive Sleep Apnea (OSA) (clinicaltrials.gov) - P3 | N=1280 | Enrolling by invitation | Sponsor: Apnimed | Recruiting ➔ Enrolling by invitation

Enrollment status • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Parallel-Arm Study to Compare AD109 to Placebo with Patients with OSA (SynAIRgy Study) (clinicaltrials.gov) - P3 | N=740 | Active, not recruiting | Sponsor: Apnimed | Recruiting ➔ Active, not recruiting

Enrollment closed • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Continuation Protocol for Obstructive Sleep Apnea (OSA) (clinicaltrials.gov) - P3 | N=1280 | Recruiting | Sponsor: Apnimed

New P3 trial • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

APC-APN-201: Study That Tests AD109 in Patients Taking GLP-1 Drugs (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Apnimed | Not yet recruiting ➔ Recruiting

Enrollment open • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Aroxybutynin and Atomoxetine (AD109) for the Treatment of OSA: Rationale and Design of the LUNAIRO Phase 3 Randomized, Controlled Clinical Trial (ATS 2024) - "LUNAIRO is a randomized, double-blind, controlled, parallel-arm, large, 1-year Phase 3 clinical trial designed to confirm and extend evidence of the safety and efficacy in of AD109, a combination drug targeting the key mechanism of upper airway muscle relaxation during sleep in adults with OSA."

Clinical • P3 data • Fatigue • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Study That Tests AD109 in Patients Taking GLP-1 Drugs (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Apnimed

New P2 trial • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo) (clinicaltrials.gov) - P3 | N=660 | Active, not recruiting | Sponsor: Apnimed | Recruiting ➔ Active, not recruiting

Enrollment closed • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study) (clinicaltrials.gov) - P3 | N=640 | Recruiting | Sponsor: Apnimed

Trial completion date • Trial primary completion date • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo) (clinicaltrials.gov) - P3 | N=640 | Recruiting | Sponsor: Apnimed

Trial completion date • Trial primary completion date • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study) (clinicaltrials.gov) - P3 | N=640 | Recruiting | Sponsor: Apnimed | Not yet recruiting ➔ Recruiting

Enrollment open • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

The Combination of Aroxybutynin and Atomoxetine in the Treatment of Obstructive Sleep Apnea (MARIPOSA): A Randomized Controlled Trial. (PubMed, Am J Respir Crit Care Med) - P2 | "AD109 showed clinically meaningful improvement in OSA, suggesting further development of the compound is warranted. Clinical trial registration available at www."

Clinical • Journal • CNS Disorders • Fatigue • Insomnia • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder • Xerostomia

Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo) (clinicaltrials.gov) - P3 | N=640 | Recruiting | Sponsor: Apnimed | Not yet recruiting ➔ Recruiting

Enrollment open • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Mariposa: Oral Therapy AD109 Improves Objective & Patient Reported Outcomes In OSA. Randomized, Placebo Controlled Clinical Trial (SLEEP 2023) - "Conclusion AD109 objectively and subjectively improved OSA severity in a group of patients with a wide range of AHI4 over 4 weeks of treatment. Results from the Mariposa trial are central for the design of phase 3 trials of AD109 in OSA."

Clinical • Patient reported outcomes • CNS Disorders • Insomnia • Obstructive Sleep Apnea • Sleep Disorder

Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study) (clinicaltrials.gov) - P3 | N=640 | Not yet recruiting | Sponsor: Apnimed

New P3 trial • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo) (clinicaltrials.gov) - P3 | N=640 | Not yet recruiting | Sponsor: Apnimed

New P3 trial • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

MARIPOSA: Parallel Arm Trial of AD109 and AD504 In Patients With OSA (clinicaltrials.gov) - P2 | N=294 | Completed | Sponsor: Apnimed | Active, not recruiting ➔ Completed

Trial completion • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

MARIPOSA: Parallel Arm Trial of AD109 and AD504 In Patients With OSA (clinicaltrials.gov) - P2 | N=280 | Active, not recruiting | Sponsor: Apnimed | Recruiting ➔ Active, not recruiting

Enrollment closed • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Combination of atomoxetine with the novel antimuscarinic aroxybutynin improves mild to moderate OSA (WSS 2022) - "This study provides further support that a pharmacological intervention for OSA, namely the combination of atomoxetine and aroxybutynin offers promising results.  Additional development of this compound and others is warranted.   This study was funded by Apnimed."

CNS Disorders • Obstructive Sleep Apnea • Sleep Disorder

Apnimed Announces Dosing of First Patient in Phase 2 MARIPOSA Confirmatory Trial of AD109, a Potential Nighttime Oral Treatment for Obstructive Sleep Apnea (OSA) (Businesswire) - "Apnimed...today announced the dosing of the first patient in the Phase 2b MARIPOSA study of AD109, the company’s lead investigational oral medication for the treatment of OSA. The study is designed to be informative for the upcoming AD109 Phase 3 program."

Trial status • CNS Disorders • Obstructive Sleep Apnea • Sleep Apnea • Sleep Disorder