Apnimed, a clinical-stage company focused on advancing pharmacologic treatments for sleep apnea and related disorders, 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,” says Paul Wick, lead portfolio manager of the Seligman Technology Group at Columbia Threadneedle Investments, in a release. “We are confident that the Apnimed team has the expertise and experience to execute these clinical programs and bring this therapeutic option to patients.”

Nicholas Pritzker, principal of Tao Capital Partners, says in a release, “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. The vast majority of patients want a simple and convenient solution which a daily pill taken before sleep can offer.”

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Larry Miller, MD, Apnimed CEO, says in a release, “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. 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—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 profile in a Phase 1 study, paving the way for Phase 2 studies of AD109.

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