Apnimed's sleep apnea pill meets main goal in late-stage study

ResMed Inc.
Koninklijke Philips N.V. Sponsored ADR

ResMed Inc.

RMD

0.00

Koninklijke Philips N.V. Sponsored ADR

PHG

0.00

- 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.