CAMBRIDGE, Mass. August 28, 2023 – Apnimed, Inc., a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies for the treatment of obstructive sleep apnea (OSA) and related disorders, including its lead oral treatment candidate AD109, announced today that Fierce Biotech named it as one of 2023’s “Fierce 15” biotechnology companies. The selection is a recognition given to the industry’s most innovative and promising biotechnology companies who are pushing the boundaries in the clinic and beyond.
Apnimed is working to transform the treatment of sleep apnea based on a simple idea – patients with OSA could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Apnimed’s lead development program for AD109 (aroxybutynin/atomoxetine) targets the neurologic control of upper airway muscles to maintain an open airway during sleep. AD109 is a potential first-in-class, novel, investigational combination and is designed to treat OSA patients across a broad spectrum of disease severity. As an oral medication, AD109 has the potential to transform the medical device-focused treatment paradigm for OSA patients.
“For the past 21 years, we have assessed hundreds of early-stage companies for inclusion in the ‘Fierce 15’ special report. To curate this list, we consider a diverse range of factors, including the robustness of their technology, partnerships, venture support and their competitive positioning within the market,” said Ayla Ellison, Editor-in-Chief, Fierce Life Sciences and Healthcare. “Our special report celebrates innovation and creativity in the face of intense competition.”
“We’re delighted Apnimed is being recognized by Fierce Biotech for the work we’re doing to solve a challenging health issue impacting millions of Americans that other biopharmaceutical companies have overlooked,” said Larry Miller, MD, Chief Executive Officer of Apnimed.
“There are more than 45 million Americans who have sleep apnea, and millions of them cannot tolerate the standard-of-care positive air pressure therapy devices, such as CPAP, and need new treatment options urgently,” Miller said. “Right now, fewer than half of the many people prescribed these mechanical nighttime devices are fully compliant long term, leaving a significant population untreated, undertreated and at risk. Apnimed is working to find effective solutions that can meet this need.”
Apnimed ended 2022 both by announcing positive Phase 2b results on AD109 and by completing an oversubscribed $79.75 million Series C extension financing. The company is initiating its Phase 3 clinical studies for AD109. Apnimed, in partnership with grassroots community organizations, has expanded and invested substantially in patient recruitment efforts from underrepresented racial and ethnic communities for its Phase 3 program. The company’s objective is to increase enrollment and participation of minority populations to achieve a diverse group of clinical trial participants that will be more representative of real-world populations.
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AD109 has the potential to be the first oral pharmacologic that both treats the underlying cause of OSA, airway obstruction at night, and improves daytime consequences of OSA, such as fatigue. It is a potential 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 current standard of care 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.
Apnimed Investor Contact:
Kendall Investor Relations