wilkes

I have a couple of relatives that use the machines. An oral treatment would be a real game changer.

Sleep Apnea one of the most OVERDIAGNOSED diseases. The amount of revenue that has been generated by the lavish way in which it's diagnosed is huge. Medical equipment manufacturers (most of which are offshore) should be eternally grateful. As a victim of this scam, I've made a point of contacting others and found that I'm not an isolated case.

This week was a win for millions of people with both obstructive sleep apnea (OSA) and obesity who are untreated or not achieving success with current treatments. Congratulations to Lilly for their success of the SURMOUNT-OSA Phase 3 study of tirzepatide in the treatment of moderate to severe OSA in people with obesity.

As you consider the impact of Lilly's news, below is

OSA is one of the most common and serious sleep disorders, affecting as many as 80 million Americans and nearly one billion worldwide. Unlike many other common health disorders and diseases, OSA is vastly underdiagnosed and undertreated. Awareness and understanding of OSA among the general public is relatively low, despite the fact that it significantly increases one's risk for serious comorbidities like hypertension, diabetes, cardiovascular disease and stroke.

Most people diagnosed with OSA are prescribed devices such as continuous positive airway pressure (CPAP). Less than half continue to use the device long term.

News of new innovations in OSA management, like tirzepatide, may help to motivate people living with OSA to seek diagnosis and engage their healthcare providers in productive conversations about much needed new treatment approaches.

The SURMOUNT-OSA study is good news for those with obesity who also have OSA. There is still more work to do because approximately 60% of people with OSA are not obese* and therefore may not be candidates for tirzepatide as a treatment for OSA at this time.

Virtually all people with OSA, whether obese or not, have both an anatomic defect (upper airway narrowing) and a sleep-related neuromuscular defect (decreased upper airway muscle tone, controlled by the brain), which together cause OSA. Tirzepatide is designed to address the anatomic defect through a reduction in weight. Further options may be needed to treat OSA.

Apnimed is developing the novel medication AD109 that has the potential to be the first once-daily oral treatment for OSA. AD109 is being developed to directly target the neuromuscular root cause of OSA. It is designed to address the disorder's underlying neurobiology to activate upper airway muscles and maintain an open airway during sleep. No FDA-approved drugs are currently available to address the neuromuscular cause of OSA.

Apnimed is currently conducting two large registration-enabling Phase 3 randomized controlled trials (LunAIRo and SynAIRgy) examining the use AD109 in patients: who are either intolerant of or refuse to use CPAP whether obese or notin a BMI range that includes healthy, overweight and obesity patientswith all types of OSA, whether mild, moderate or severe

A subset of OSA patients in the Phase 3 trials are also eligible to receive both Apnimed's drug and GLP1 medications like tirzepatide

Topline results of the Apnimed trials are expected next year.

Change is coming in OSA, and Apnimed is a company to watch. We look forward to a future with more treatment options for the millions of people living with OSA. Stay tuned for more updates in the months ahead.

About AD109

AD109 has the potential to be the first oral pharmacologic that could both treat the underlying nighttime airway obstruction and hypoxia that characterize OSA, as well as improve the daytime consequences of OSA, such as fatigue. It is a first-in-class, novel, investigational combination dosed once daily at bedtime and is designed to treat OSA patients across a broad spectrum of disease severity. AD109 combines Apnimed's novel selective antimuscarinic (aroxybutynin) with a selective norepinephrine reuptake inhibitor (atomoxetine). AD109 targets key neurological pathways in OSA that activate upper airway dilator muscles to maintain an open airway during sleep. AD109 has the potential to become a safe, effective, and convenient treatment for OSA, addressing some of the key limitations of approved treatments that can be poorly tolerated (e.g., CPAP and oral devices) and/or invasive (e.g., surgery or implanted devices). AD109 has been granted Fast Track designation by the FDA and is currently in Phase 3.