CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apnimed, a clinical-stage company focused on advancing pharmacologic treatments for sleep apnea and related disorders, announced today that it has raised $25 million in a Series B financing led by existing investor, Morningside Ventures, and joined by new investors, Seligman Investments and Tao Capital Partners. The proceeds will support Apnimed’s ongoing development and commercialization plans. The company is advancing its lead program, AD109, an oral disease-modifying therapeutic for the treatment of Obstructive Sleep Apnea (OSA), which is currently in late-stage Phase 2 clinical trials.
“Apnimed’s approach with a once-daily oral medication to address the root cause of the condition could not only be a game changer for patients, but also represents a significant market growth opportunity,” said Paul Wick, lead portfolio manager of the Seligman Technology Group at Columbia Threadneedle Investments. “We are confident that the Apnimed team has the expertise and experience to execute these clinical programs and bring this therapeutic option to patients.”
“We are excited to support Apnimed’s mission of developing an oral medication for sleep apnea that has the potential to transform and grow the market dramatically,” noted Nicholas Pritzker, Principal of Tao Capital Partners. “The vast majority of patients want a simple and convenient solution which a daily pill taken before sleep can offer.”
Sleep apnea is a prevalent and debilitating medical condition that has no pharmaceutical treatment options. Mechanical solutions such as CPAP machines have poor compliance long-term, leaving a significant population of patients untreated, undertreated and at risk. Many patients with sleep apnea are reluctant to seek diagnosis and treatment since the current treatment options, mechanical airway pressure devices and neurostimulation implants, while effective, are often associated with significant obstacles to uptake and long-term compliance.
“People living with Obstructive Sleep Apnea need a safe, effective, and easy-to-use treatment option that addresses the underlying neurologic cause of the disease. The proceeds of this financing enable us to initiate our Phase 3 program for AD109,” said Larry Miller, M.D., Chief Executive Officer of Apnimed. “We are pleased to welcome Seligman and Tao Capital Partners to our syndicate and greatly appreciate Morningside’s continued support and recognition of our science and our goal to help address the needs of patients living with OSA.”
In late 2020, Apnimed initiated a Phase 2 study of AD109 for the treatment of mild to severe OSA (NCT04580394), and in January 2021, the company initiated a second Phase 2 study of AD109, in mild to moderate OSA (NCT04631107). Data from these studies are anticipated in the second quarter of this year with a Phase 3 registrational study anticipated to follow. If successful, AD109 could offer an entirely new approach to treating OSA with a once-daily, oral medication that addresses the underlying biology of the disease.
AD109 combines a selective norepinephrine reuptake inhibitor (atomoxetine) with a novel new chemical entity (NCE) – a selective antimuscarinic (aroxybutynin). Proof-of-concept for the AD109 program was demonstrated by Apnimed in a Phase 2, parallel group dose-finding study of the combination of atomoxetine and racemic oxybutynin. That study provided evidence of safety and efficacy in the treatment of OSA with a norepinephrine reuptake inhibitor (NRI) + antimuscarinic combination in 140 patients – indicating that a pharmacologic approach could treat the underlying neurobiology of OSA. Aroxybutynin has been shown to be safe and well tolerated and had a favorable pharmacokinetic (PK) profile in a Phase 1 study, paving the way for Phase 2 studies of AD109.
Apnimed’s lead product candidate, AD109, targets the neurologic control and facilitates the activation of the upper airway dilator muscles to maintain an open airway during sleep. AD109 is a first-in-class, oral pharmaceutical combination dosed once-daily at bedtime, designed to treat OSA patients across a broad spectrum of disease severity. AD109 combines a selective norepinephrine reuptake inhibitor (NRI) with a low dose of our novel NCE selective antimuscarinic. The investigational drug is designed to be safe, effective, and convenient, addressing the key limitations of the current standard of care treatments.
About Obstructive Sleep Apnea
Obstructive Sleep Apnea (OSA) is one of the most common and serious sleep disorders and affects approximately six percent of women and 13 percent of men in the U.S., totaling more than 25 million Americans. OSA is characterized by partial or complete upper airway occlusion that occurs during sleep which may lead to poor sleep, and in the long-term, hypertension, diabetes, cardiovascular disease, strokes, and early mortality. OSA is also a major cause of motor vehicle accidents and workplace injuries. Over 80 percent of diagnosed patients are prescribed positive pressure devices such as CPAP, but only 30-40 percent are compliant long-term, leaving a significant population untreated and at risk. Apnimed expects its pharmacologic therapies to transform treatment of this serious sleep disorder.
Apnimed is a clinical-stage company working to transform the treatment of sleep apnea based on a simple idea – patients will benefit from safe and effective oral drug treatment. Based in Cambridge, Mass., the company is developing a portfolio of novel pharmacologic therapies for sleep apnea and related disorders. To learn more visit Apnimed.com or follow the company on LinkedIn and Twitter.