A Cambridge-based pharmaceutical startup, Apnimed, has emerged in the spotlight with the announcement of encouraging results from its recent clinical trials aimed at treating obstructive sleep apnea, a condition marked by interruptions in breathing during sleep that can lead to serious health issues.
Founded in 2017, Apnimed claims that its experimental oral medication has shown to reduce the frequency of breathing interruptions—known as apneas—by an impressive 46.8% per hour during sleep, compared to a mere 6.8% reduction seen in participants receiving a placebo.
For the millions affected by sleep apnea—approximately 30 million Americans according to the American Academy of Sleep Medicine—treatment methods typically involve specialized mouthpieces, continuous positive airway pressure (CPAP) machines, or, unfortunately, no treatment at all.
Apnimed cites an even larger estimate, suggesting about 80 million Americans deal with sleep apnea, with 23 million having filed insurance claims related to the condition over the last five years, as noted by Barry Wohl, the company’s chief business officer.
Their clinical trial engaged 1,300 participants who either had never used a CPAP machine or had previously tried one but discontinued its use.
Wohl emphasized the pressing need for more user-friendly treatment options, stating, “The field is kind of crying out for an easy-to-use, easy-to-try therapy like an oral medication would be.”
Apnimed is preparing to submit its request for FDA review early next year, which, if accepted, could pave the way for a groundbreaking new treatment.
The drug itself is a combination therapy that incorporates two active ingredients into a single pill, taken at bedtime.
This innovative medication works by increasing muscle tone in the throat during the night, preventing the airway from collapsing and causing apneas.
The trials encompassed patients with mild, moderate, and severe forms of sleep apnea, showcasing the potential for significant improvements in the severity of their condition.
In contrast, the FDA recently approved Zepbound by Eli Lilly & Co., a weight loss drug intended to address sleep apnea indirectly through weight reduction—injections rather than oral medication—which highlights the novelty of Apnimed’s approach.
Wohl articulated the difference, asserting that while Zepbound represents a long-term solution, Apnimed’s drug offers a near-term treatment that activates upper airway muscles without necessitating weight loss.
Despite the optimism surrounding Apnimed’s medication, some caution is warranted.
According to Dr. Robert Thomas, Director of the Sleep Medicine Center at Beth Israel Deaconess Medical Center, while the drug may enhance oxygen levels during sleep, the overall improvements in sleep quality and daytime performance may not be as marked as some hope for.
Thomas recognizes the pill’s potential for certain patients—especially those with mild to moderate sleep apnea and minimal accompanying health issues—but he stresses that it may not be a universal solution for all sleep apnea sufferers.
Apnimed has attracted significant financial backing, having raised over $280 million since its inception.
The company, co-founded by researchers from Brigham and Women’s Hospital and headquartered in Cambridge, operates largely in a virtual setting, with about one-third of its approximately 75 employees based in the Boston area.
Despite this financial backing, Apnimed has not yet announced a public stock offering, as Wohl noted.
Funding challenges loom large in the scientific community, as one of Apnimed’s founders, Andrew Wellman, expressed concern about impending cuts to federal funding from the National Institutes of Health (NIH), which could reduce research capabilities significantly.
Funding of roughly $500,000 from the NIH supported early research for the medication in Wellman’s lab, with additional financial support coming from a private individual impacted by sleep apnea.
He cautioned that a substantial reduction in NIH funding could hinder the progress of promising scientific research, highlighting the long maturation period necessary for scientific breakthroughs.
As for insurance coverage for Apnimed’s medication, clarity remains elusive.
Wohl reassured that the company is in discussions with major insurance providers to outline how the medication might be categorized and how reimbursement could be structured once it secures FDA approval.
Apnimed is keen on ensuring accessible treatment options for patients who may benefit from its innovative oral pill.
The emerging developments surrounding Apnimed’s novel approach to treating sleep apnea reflect a significant leap towards integrating simpler, more effective treatment options for a widely prevalent condition.
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