Standard treatment for breathing issues caused by obstructive sleep apnea typically involves using a medical device, such as a continuous positive airway pressure (CPAP) machine. However, many individuals find wearing the CPAP mask uncomfortable. Apnimed, a startup company, has developed an experimental drug, AD109, that could offer a more convenient alternative. Results from a pivotal study on this pill support Apnimed’s plans for submitting it to the FDA and potentially challenging a major pharmaceutical company.
Apnimed’s approach targets muscles that play a role in obstructive sleep apnea (OSA), a condition affecting an estimated 80 million people in the U.S. OSA involves the repeated collapse of the upper airway during sleep, leading to breathing interruptions and periods of oxygen deprivation. Anatomical abnormalities and muscle dysfunction contribute to OSA, and while surgery can address the issue, it is invasive. AD109 combines two compounds, aroxybutynin and atomoxetine (Strattera), in a single nightly pill. This combination aims to activate upper airway muscles during sleep, keeping the airway open. Research at Brigham & Women’s Hospital showed that these compounds can increase muscle tone in the upper airway, reducing obstructions.
Results from a Phase 3 trial involving 646 adults with mild, moderate, or severe OSA who cannot tolerate or refuse CPAP therapy showed a significant reduction in the apnea-hypopnea index scores for those taking AD109 compared to a placebo. The drug was well-tolerated, with common side effects like dry mouth and insomnia. Apnimed plans to present full Phase 3 results later this year and aims to submit AD109 to the FDA in early 2026.
While Apnimed focuses on an oral OSA medication, other companies like Incannex Healthcare are also developing oral treatments for OSA. Incannex’s IHL-42X, a combination of acetazolamide and dronabinol, has shown promise in reducing the apnea-hypopnea index. Both drugs target different mechanisms to improve breathing during sleep. Incannex is conducting clinical trials for IHL-42X in the U.S., with plans to expand to the UK and EU.
Apnimed recently acquired global rights to sulthiame, a carbonic anhydrase inhibitor, for OSA treatment. This medication, which works differently from AD109, will be developed for OSA and other sleep disorders through a joint venture with Shionogi. Apnimed’s last financing round in 2023 raised $80 million, extending its Series C funding to $142.2 million to support the development of AD109. La compañía dice que ha recaudado $270 million hasta la fecha.
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