— Phase 3 Trials Expected to Begin Enrollment in Second Quarter of 2023, Subject to Discussions with the FDA
Apnimed, Inc., a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies for the treatment of obstructive sleep apnea (OSA) and related disorders, announced today that it has secured $79.75 million in an oversubscribed financing round that extends its Series C financing to a total of $142.25 million. The financing was led by existing investor Alpha Wave Ventures and included existing investors Sectoral Asset Management, Columbia-Seligman Investments and Tao Capital Partners, among others.
“This substantial additional investment is a significant vote of confidence by our investors” Tweet this
The financing will fund the planned Phase 3 trials for Apnimed’s lead candidate, AD109 (aroxybutynin + atomoxetine), that has the potential to be the first oral treatment for OSA. Enrollment for the clinical trials is expected to begin in the second quarter of 2023 subject to discussions with the U.S. Food and Drug Administration (FDA).
“This substantial additional investment is a significant vote of confidence by our investors,” said Larry Miller, M.D., Chief Executive Officer of Apnimed. “There is a tremendous unmet clinical need for new pharmaceutical treatment options for OSA, and this funding recognizes that need and the unique opportunity for AD109 to change the treatment paradigm for this serious disorder. With this funding, Apnimed can move forward with the late-stage clinical trials that will form the basis for approval of AD109.”
“The results of the Phase 2 MARIPOSA study were highly promising and informed the design of the two Phase 3 trials to identify those patients who could benefit from a new oral treatment,” said Chris Dimitropoulos, Managing Director, Alpha Wave Ventures. “We’re excited to lead this financing, which will allow Apnimed to conduct its registration Phase 3 trials for this important alternative for the large number of patients with OSA who are unable tolerate current therapies.”
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, 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/or invasive (e.g., surgery or implanted devices).
AD109 has been granted Fast Track designation by the FDA.
About Obstructive Sleep Apnea
Obstructive Sleep Apnea is one of the most common and serious sleep disorders. It is estimated to affect more than 35 million Americans, though underdiagnosis continues to be a serious problem and the number of affected Americans may be far greater. OSA is characterized by partial or complete upper airway obstruction that occurs during sleep, which often leads to poor sleep, and in the long term, has been shown to exacerbate hypertension, diabetes, cardiovascular disease, and stroke. Additionally, OSA can impair work productivity, reduce daytime functional abilities, and lower quality of life. Sleep-related muscular relaxation driven by the central nervous system is the key neurologic mechanism that causes OSA. In patients with OSA, a reduction in neuromuscular control of the upper airway during sleep leads to a corresponding relaxation of the upper airway dilator muscles. The vast majority of diagnosed patients are prescribed positive air pressure therapy devices such as continuous positive airway pressure, or CPAP, but many patients are dissatisfied with these mechanical nighttime devices and fewer than half are compliant long term, leaving a significant population untreated, undertreated and at risk.
Apnimed is a clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Apnimed’s lead development program targets the neurologic control of upper airway muscles to maintain an open airway during sleep. Based in Cambridge, Mass., the company is developing a portfolio of novel pharmacologic therapies for sleep apnea and related disorders.
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