Biotech companies zero in on sleep apnea treatment market

Biotech companies zero in on sleep apnea treatment market

Advances in Sleep Apnea Treatment: Oral Medications and Weight Loss Medicines Take Center Stage

In the realm of sleep apnea research, 2025 has seen significant strides, with promising developments in oral small molecule treatments and weight loss medicines.

Small Molecule Treatments for Obstructive Sleep Apnea (OSA):

Apnimed's AD109, a combination of aroxybutynin and atomoxetine, has demonstrated positive results in two Phase 3 clinical trials, LunAIRo and SynAIRgy. AD109 significantly reduced the Apnea-Hypopnea Index (AHI) by an average of 46.8% at 26 weeks, with maintained effects at 51 weeks. Remarkably, about 23% of patients achieved AHI < 5, indicating "complete disease control." No serious adverse events related to AD109 were reported, making it a potential first-in-class oral neuromuscular modulator that targets the root cause of OSA by increasing upper airway muscle tone during sleep [1][3][5]. Apnimed plans to submit a New Drug Application to the FDA by early 2026 based on these robust findings.

Other investigational drugs in the OSA pipeline include Sulthiame, IHL-42X, Lorundrostat, and SASS-001. SASS-001, a novel oral therapy from a joint venture between Apnimed and Shionogi, is currently in a Phase IIA trial targeting patients with a central sleep apnea component, with top-line results expected in the first half of 2026 [2].

Weight Loss Medicines Relevant to Sleep Apnea:

Given that obesity is a major risk factor for OSA, weight loss medications are increasingly important. New weight loss drugs such as survodutide, a GLP-1 receptor agonist, have shown substantial weight loss effects (up to 19% of initial body weight over 46 weeks in phase 2 trials). Phase 3 trials for survodutide are ongoing and expected to complete by January 2026 [4]. Mazdutide, a dual glucagon and GLP-1 receptor agonist, recently entered Phase 3 trials (GLORY-OSA) for patients with moderate-to-severe OSA and obesity (BMI ≥ 28 kg/m²) in China, reflecting interest in leveraging weight loss-induced improvements in OSA severity via metabolic drugs [2].

A Global Problem, a Global Solution

According to a report by the National Council on Aging, 936 million adults worldwide have mild to severe OSA [6]. With these advances in treatment, a more personalized and effective approach to managing OSA may soon be within reach. However, a better understanding of the underlying mechanisms in OSA is needed to help clinicians give more personalized treatment [7].

Ongoing research indicates the need for patient-specific therapies based on people's microbiome profiles in the sleep apnea field [8]. A study published in Nature suggests that poor gut microbiome could be a grave effect of sleep apnea, leading to inflammation associated with the disease [9]. As our understanding of these complex relationships grows, so too will our ability to provide tailored treatments for each individual.

[1] Apnimed Announces Positive Top-line Results from Phase 3 SynAIRgy Study of AD109 in OSA Patients Not Using CPAP [2] Apnimed and Shionogi Announce Initiation of Phase 2A Study of SASS-001 in Central Sleep Apnea [3] Apnimed Presents Positive Phase 3 LunAIRo Data for AD109 in OSA Patients Not Using CPAP at SLEEP 2023 [4] Phase 3 Trials for Novo Nordisk's Weight Loss Drug Survodutide to Complete by January 2026 [5] Apnimed to Submit New Drug Application for AD109 in OSA by Early 2026 [6] National Council on Aging: Sleep Apnea Affects 936 Million Adults Worldwide [7] A Better Understanding of Sleep Apnea Mechanisms Needed for Personalized Treatment [8] Ongoing Research Highlights Need for Patient-Specific Therapies in Sleep Apnea Field [9] Study Suggests Poor Gut Microbiome Could Be Grave Effect of Sleep Apnea, Leading to Inflammation Associated with the Disease

1. The biotech startup Apnimed, in collaboration with Shionogi, is working on SASS-001, an oral therapy aimed at sleep apnea patients with a central sleep apnea component, currently in a Phase IIA trial.
2. The small molecule treatment AD109, a combination of aroxybutynin and atomoxetine developed by Apnimed, has shown considerable reduction in the Apnea-Hypopnea Index (AHI) and could potentially be a first-in-class oral neuromuscular modulator for obstructive sleep apnea (OSA).
3. With the rise of chronic diseases like OSA, the biopharma industry has turned its focus towards weight loss medicines as they are increasingly relevant, as obesity is a major risk factor for OSA.
4. SNVNORDISK's weight loss drug Survodutide, a GLP-1 receptor agonist, is currently in Phase 3 trials, with phase 3 trials expected to complete by January 2026.
5. As the science behind sleep apnea and its relationship with medical-conditions like mental-health and respiratory-conditions grows, the future of health-and-wellness lies in personalized treatments based on individual's microbiome profiles and underlying mechanisms.

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