Apnimed’s extension financing round raised $79.75m (€75.24m), which were raised on the back of the company’s work to progress oral therapies for the treatment of obstructive sleep apnea (OSA) and related disorders.
The extension round brings the company’s total raise during its Series C funding to $142.25m.
According to the company, the funds will be used for two planned Phase III trials for AD109 (aroxybutynin and atomoxetine), which could become a first-in-class treatment, should it progress to commercialization.
Apnimed outlined that it plans to move forward with the late-stage trials in the second quarter of 2023, and will begin enrolling patients onto the trials at this time, subject to discussions with the US Food and Drug Administration (FDA).
Chris Dimitropoulos, MD of Alpha Wave Ventures, a venture capital firm that led the investment round, stated that AD109 could become an alternative therapy for patients who are unable to tolerate current solutions for OSA. Current treatment options include continuous positive airway pressure (CPAP) machines, surgical interventions and medical devices.
In October 2022, Apnimed posted positive topline results from a Phase IIb trial, where it met the primary endpoint by showing a statistically significant reduction in the Apnea-Hypopnea Index.
The therapy works by targeting neurological pathways in OSA that activate upper airway dilator muscles to maintain an open airway during sleep. The treatment is an oral therapy taken once daily before sleeping.
AD109 combines a selective norepinephrine reuptake inhibitor (NRI), atomoxetine, with a novel selective antimuscarinic, aroxybutynin. The potential treatment received fast track designation from the FDA in June 2022.
The drug candidate is also being explored for an indication to treat snoring, for which the company is moving into Phase II trials.
Beyond AD109, Apnimed also has AD504 (atomoxetine and trazodone) in its pipeline, which is being tested as a monotherapy, and alongside AD109 to treat OSA.
The company released data for the drug candidate in June 2022, which Apnimed’s CEO, Larry Miller, stated showed the potential for AD504 to become a ‘follow on’ treatment to AD109.
It is estimated that more than 35 million individuals in the US alone suffer from OSA, making the potential market for an effective treatment particularly large. Investors clearly saw the potential for the area, as Apnimed was able to announce that its Series C funding round extension had been oversubscribed.