Apnimed’s extended funding round raised $79.75 million (€75.24 million). It was raised against the backdrop of the company’s efforts to advance oral therapies for the treatment of obstructive sleep apnea (OSA) and related disorders.
The extended round brings the total amount raised during the company’s Series C funding to $142.25 million.
According to the company, the funding will be used for two planned Phase III trials of AD109 (alloxybutynin and atomoxetine).
Apnimed outlined that it plans to proceed with the late-stage trial in the second quarter of 2023 and, subject to discussion with the U.S. Food and Drug Administration (FDA), plans to begin enrolling patients into the trial at this time. did.
Chris Dimitropoulos, MD at Alpha Wave Ventures, the venture capital firm that led the investment round, said AD109 could be an alternative therapy for patients who cannot tolerate OSA’s current solutions. Current treatment options include continuous positive airway pressure (CPAP) machines, surgical interventions, and medical devices.
In October 2022, Apnimed announced positive topline results from its Phase 2b trial. The trial met its primary endpoint with a statistically significant reduction in the Apnea Hypopnea Index.
This therapy works by targeting the neural pathways in OSA that activate the upper airway dilator muscles to keep the airways open during sleep. Treatment is an oral therapy taken once daily at bedtime.
AD109 is a combination of atomoxetine, a selective norepinephrine reuptake inhibitor (NRI), and alloxybutynin, a novel selective antimuscarinic agent. The candidate therapy received Fast Track designation from the FDA in June 2022.
The drug candidate is also being investigated for indications for treating snoring, for which the company is moving into a Phase II trial.
Beyond AD109, Apnimed also has AD504 (atomoxetine and trazodone) in its pipeline, which is being tested as a monotherapy alongside AD109 to treat OSA.
The company released data for this drug candidate in June 2022. Apnimed CEO Larry Miller says AD504 has shown potential to be a “follow-on” treatment for his AD109.
With over 35 million individuals estimated to suffer from OSA in the United States alone, the potential market for effective treatments is particularly large. Investors were clearly aware of the potential in this space as Apnimed was able to announce that the extension of its Series C funding round was oversubscribed.