Apnimed's sleep apnea pill meets main goal in late-stage study
ResMed Inc. RMD | 0.00 | |
Koninklijke Philips N.V. Sponsored ADR PHG | 0.00 |
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 RMD.N and Philips PHG.AS 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 LLY.N 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.
