AD109 advances as Apnimed completes early enrollment for its LunAIRo phase 3 study, examining its efficacy and safety for obstructive sleep apnea treatment.


Summary: Apnimed, a clinical-stage pharmaceutical company, has completed early enrollment for its LunAIRo phase 3 study, evaluating the efficacy and safety of its lead candidate AD109 for treating obstructive sleep apnea (OSA). AD109, a potential first oral pharmacologic treatment for OSA, is aimed at patients intolerant of or refusing PAP therapy. The study includes a diverse range of OSA patients and will present its design at the ATS 2024 International Conference. Topline phase 3 data for both LunAIRo and the ongoing SynAIRgy trial are expected in mid-2025.

Key Takeaways: 

  • Apnimed has successfully completed early enrollment for its LunAIRo phase 3 study, indicating strong interest in new OSA treatments.
  • AD109, Apnimed’s lead candidate, could become the first oral pharmacologic therapy for obstructive sleep apnea, targeting patients who are intolerant of or refuse PAP therapy.
  • The study’s rationale and design will be featured at the ATS 2024 International Conference, with topline phase 3 data for both LunAIRo and SynAIRgy trials expected in mid-2025.

Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies for the treatment of obstructive sleep apnea (OSA) and related disorders, announced the early completion of enrollment in its LunAIRo phase 3 study designed to examine the efficacy and safety of its lead candidate AD109 (aroxybutynin/atomoxetine) compared to placebo at six months and one year. 

The company believes AD109 has the potential to be the first nighttime oral pharmacologic treatment for people with OSA who are either intolerant of or refuse to use positive airway pressure (PAP) therapy. Apnimed’s second, large pivotal phase 3 randomized controlled trial, SynAIRgy, is continuing its enrollment. Topline phase 3 data for both LunAIRo and SynAIRgy are expected in mid-2025.

“There are no FDA-approved drugs currently available to address the neuromuscular dysfunction that causes OSA. The LunAIRo Study is designed to evaluate the potential of AD109 to address the underlying neurobiology of OSA by activating the upper airway muscles and maintaining an open airway during sleep,” says Sanjay R. Patel, MD, primary investigator in the LunAIRo clinical study and director of the UPMC Comprehensive Sleep Disorders Clinical Program, in a release. “Because fewer than half of the people who are prescribed devices such as PAP therapy consistently use them long term and many others cannot or will not use them, new options are urgently needed to address the chronic undertreatment of OSA among millions of Americans.”

LunAIRo at ATS 2024 International Conference

The rationale and design of the LunAIRo phase 3 Study will be featured in a poster presentation at the American Thoracic Society’s (ATS) International Conference in San Diego on May 20. 

The LunAIRo Study is a randomized, double blind, placebo-controlled, parallel-arm one-year study of AD109 in adults with OSA who are intolerant of or refuse PAP therapy. The LunAIRo study examines the use of AD109 in a range of OSA patients across all types of OSA from mild to severe and ranges of body mass index (BMI) from normal to obese.

“We completed the enrollment of LunAIRo ahead of schedule, signaling that there is strong interest in innovative new approaches to treating OSA among both clinicians and people with OSA,” says Larry Miller, MD, chief executive officer of Apnimed, in a release. “Studying AD109 across a broad range of people who have OSA is an important consideration in the LunAIRo Study. We believe AD109 represents a significant market opportunity, with the potential to help patients with OSA across a broad spectrum of severity and BMI.”

Presentation details:

Poster: 7597 

Title: Aroxybutynin and Atomoxetine (AD109) for the Treatment of OSA: Rationale and Design of the LunAIRo Phase 3 Randomized, Controlled Clinical Trial

Session: B80-3: OSA 2.0: Leveling Up the Sleep Apnea Tool Kit

Time: Monday, May 20, 11:30-1:15 PM PT

Location: San Diego Convention Center, Area D (Hall A-B2, Ground Level)

Presenter: Sanjay R. Patel, MD, principal investigator of the LunAIRo Study and director of the UPMC Comprehensive Sleep Disorders Clinical Program in Pittsburgh

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