CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic treatments to address obstructive sleep apnea (OSA) and related disorders, announced today that it has raised $62.5 million of committed capital in a Series C financing. New investor, Sectoral Asset Management, led the round. Also participating were new investors Alpha Wave Ventures, NexPoint, and others, joining existing investors Morningside Ventures, Seligman Investments, and Tao Capital Partners.
The proceeds from the Series C financing will support Apnimed’s plans to advance its lead program, AD109, into Phase 3 development. The company will also strategically grow the team to support further program development and initial commercial plans.
“Patients with obstructive sleep apnea are in need of new pharmaceutical treatment options to manage this serious, life-altering, and life-threatening disease,” said Larry Miller, M.D., Chief Executive Officer of Apnimed. “We’re pleased to have assembled this well-respected and committed group of investors as we seek to change the treatment paradigm for OSA and related sleep disorders.”
As part of the financing, Stefan Larson, Ph.D., Partner at Sectoral Asset Management, and Chris Dimitropoulos, Managing Director, Biotechnology at Alpha Wave Ventures, will join Apnimed’s Board of Directors. Isaac Cheng, M.D., of Morningside Capital, also joins the Board to replace Gerald Chan, Sc.D.
“Apnimed has made remarkable progress in developing a robust pipeline of therapeutic options for OSA,” said Stefan Larson, Ph.D. “We are excited to support Apnimed with their plans to advance their lead product, AD109, into Phase 3 as a potential treatment for this serious and highly prevalent condition.”
“We believe that a pharmaceutical therapeutic approach to treating OSA represents a major and welcome shift both for the field and for people living with this serious disease,” said Chris Dimitropoulos. “We look forward to seeing additional data from Apnimed’s Phase 2 MARIPOSA study later this year that will inform the final design of the planned Phase 3 studies and to supporting Apnimed through their continued progress toward approval.”
AD109 is Apnimed’s potential first-in-class, investigational, oral pharmacologic combination dosed once daily at bedtime. It is designed to treat OSA patients across a broad spectrum of disease severity. AD109 targets key neurological pathways in OSA that cause upper airway closure during sleep. AD109 combines a selective norepinephrine reuptake inhibitor (atomoxetine) with Apnimed’s likely new chemical entity (NCE) – a selective antimuscarinic (aroxybutynin) – intended to activate the upper airway dilator muscles and maintain an open airway during sleep. The investigational drug combination has the potential to become a safe, effective, and convenient treatment for OSA, addressing some of the key limitations of the current standard of care treatments. It is currently completing Phase 2 clinical trials. Following completion of the trials, Apnimed plans to meet with FDA to discuss the Phase 3 development program.
MARIPOSA (clinicaltrials.gov identifier NCT05071612) is a randomized, double-blind, placebo-controlled, parallel-arm, dose-finding one-month study designed to inform the Phase 3 dose for AD109 and advance dose-finding for AD504 in participants (n=280) with mild, moderate, and severe OSA. MARIPOSA is one of the largest clinical trials ever planned for a drug candidate that is intended to treat the underlying cause of OSA. Interested volunteers may obtain more information about the trial at MARIPOSAstudy.com.
About Obstructive Sleep Apnea
Obstructive Sleep Apnea (OSA) is one of the most common and serious sleep disorders and is estimated to affect more than 25 million Americans, though underdiagnosis continues to be a serious problem. OSA is characterized by partial or complete upper airway closure 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 functional ability, 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. Learn more at apnimed.com or follow us on Twitter and LinkedIn.