May 18 (Reuters) – Privately held biotech firm Apnimed said on Monday its experimental pill for a sleep disorder met the main goal in a late-stage trial, potentially offering a convenient alternative to device-based treatments.
Here are the details:
• The experimental treatment, AD109, is a once-daily pill taken at bedtime. It is being developed for people with obstructive sleep apnea — a condition in which the airway repeatedly collapses during sleep, lowering oxygen levels and disrupting breathing.
• In the six-month study, AD109 met the main goal of reducing the number of breathing interruptions during sleep by 55.6% from baseline versus placebo.
• The drug also improved measures of oxygen levels during sleep, Apnimed said.
• The trial enrolled 646 adults in the U.S. and Canada who had refused or could not tolerate positive airway pressure devices, such as Continuous Positive Airway Pressure machines (CPAP), a common treatment for sleep apnea.
• ResMed and Philips make sleep apnea devices such as CPAP machines, which deliver a steady flow of pressurized air to keep airways open during sleep and ensure proper breathing.
• Eli Lilly’s blockbuster drug Zepbound is also approved for the condition.
• Apnimed said 39.6% of patients taking AD109 had at least a 50% reduction in breathing interruptions while 22.3% achieved disease control.
• The drug was generally well tolerated, with dry mouth, insomnia and nausea among the most common side effects. No serious side effects related to AD109 were reported, the company said.
• Apnimed has submitted a marketing application for AD109 to the U.S. Food and Drug Administration. The company said it expects a potential FDA decision date in the first quarter of 2027, if the application is accepted for review.
(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Joyjeet Das)
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