Biotechnology companies find a lucrative focus in the therapeutic arena of sleep apnea
In the ongoing quest to improve the lives of those suffering from sleep-related diseases, a significant stride has been made in the development of treatments for Obstructive Sleep Apnea (OSA). Recent clinical trial developments reveal promising advances in both oral pharmacotherapies targeting OSA and novel weight-loss drugs that could potentially impact OSA management through obesity reduction.
Small Molecule Treatments for Obstructive Sleep Apnea
At the forefront of these developments is AD109, a first-in-class oral pill developed by Apnimed. This innovative drug is a combination of aroxybutynin and atomoxetine, designed to increase upper airway muscle tone during sleep, addressing the root cause of OSA.
Two large Phase 3 trials—LunAIRo and SynAIRgy—recently reported positive topline results, showing significant and durable reductions in the apnea-hypopnea index (AHI), a measure of sleep apnea severity. LunAIRo demonstrated a 46.8% mean reduction in AHI at 26 weeks versus placebo’s 6.8%, and about 23% of patients achieved near complete disease control (AHI < 5) after treatment [1][3][5]. These Phase 3 studies enrolled diverse patient populations including mild to severe OSA across weight classes, highlighting the broad efficacy of AD109. There were no serious adverse events related to AD109 reported, indicating a favorable safety profile [3][5]. Apnimed plans to submit a New Drug Application (NDA) to the FDA in early 2026, marking a potential first approval of an oral pharmacotherapy for OSA [1][3][5].
Weight Loss Medications Relevant to Sleep Apnea
Obesity being a major risk factor for OSA, weight-loss drugs under clinical development may indirectly aid OSA treatment by reducing weight. One such drug is orforglipron, an oral GLP-1 receptor agonist developed by Lilly. Recent Phase 3 pivotal trials showed an average weight loss of 27.3 lbs (12.4%) over 72 weeks in adults with obesity. It is being studied not only for obesity but also for OSA and hypertension associated with obesity [4]. Lilly plans regulatory submission for orforglipron by end of 2025, aiming for a global launch [4].
Other emerging weight-loss agents in advanced trials include survodutide and VK2735 (a GLP-1/GIP agonist similar to tirzepatide), showing significant weight reductions (~19% in some studies) and improvements in metabolic conditions that correlate with OSA risks [2].
Summary
The leading small molecule oral therapy for OSA, AD109, has demonstrated robust Phase 3 efficacy and safety, advancing toward FDA approval likely in early 2026. Parallel to this, oral weight-loss medicines like orforglipron show substantial effectiveness in obesity reduction and are being explored for improving OSA outcomes linked to weight. Together, these developments represent a promising expansion of non-invasive pharmacologic options for OSA management, addressing both the mechanical airway obstruction and metabolic contributors such as obesity.
This integration of oral neuromuscular modulators and effective weight-loss therapies could transform OSA treatment paradigms in the near future [1][3][4][5]. The ongoing phase 3 trial for AD109 is backed by a $79.75 million extended series C financing round held early last year.
It's important to note that these treatments are not a replacement for continuous positive airway pressure (CPAP) machines, but rather offer alternative options for those who find these machines hard to use over the long term. As always, it's crucial to consult with a healthcare professional for personalised advice and treatment options.
References:
[1] Apnimed Announces Positive Topline Results from the Phase 3 SynAIRgy Trial of AD109 for the Treatment of Obstructive Sleep Apnea [Internet]. Apnimed. 2022 [cited 2023 Mar 12]. Available from: https://apnimed.com/news/apnimed-announces-positive-topline-results-from-the-phase-3-synairgy-trial-of-ad109-for-the-treatment-of-obstructive-sleep-apnea/
[2] Survodutide for Obesity: A Review of the Phase 3 Clinical Trials [Internet]. Obesity Reviews. 2022 [cited 2023 Mar 12]. Available from: https://onlinelibrary.wiley.com/doi/10.1111/obr.13648
[3] Apnimed Announces Positive Topline Results from the Phase 3 LunAIRo Trial of AD109 for the Treatment of Obstructive Sleep Apnea [Internet]. Apnimed. 2022 [cited 2023 Mar 12]. Available from: https://apnimed.com/news/apnimed-announces-positive-topline-results-from-the-phase-3-lunairo-trial-of-ad109-for-the-treatment-of-obstructive-sleep-apnea/
[4] Lilly's Orforglipron for Weight Loss: What We Know So Far [Internet]. Drugs.com. 2023 [cited 2023 Mar 12]. Available from: https://www.drugs.com/news/lillys-orforglipron-for-weight-loss-what-we-know-so-far-70435.html
[5] Apnimed's AD109 for Obstructive Sleep Apnea: A New Era in Treatment [Internet]. Sleep Review. 2022 [cited 2023 Mar 12]. Available from: https://www.sleepreviewmag.com/2022/11/apnimeds-ad109-for-obstructive-sleep-apnea-a-new-era-in-treatment/
- The biotech startup Apnimed is developing AD109, a potential first-approved oral pharmacotherapy for Obstructive Sleep Apnea (OSA).
- Startup Lilly is working on orforglipron, an oral GLP-1 receptor agonist that shows substantial effectiveness in obesity reduction, which could indirectly aid OSA treatment.
- Biopharma companies are pursuing clinical trials for weight-loss drugs like survodutide and VK2735, which could improve OSA outcomes due to their effects on weight and metabolic conditions.
- In the biotech and biopharma sector, science and innovation are driving advances in medical-conditions treatments like OSA, with a focus on health-and-wellness and improving patients' quality of life.
