Apnimed can now move forward with planned phase 3 clinical trials of its AD109 drug candidate for obstructive sleep apnea after it secured $79.75 million in additional financing from investors.
The trials will help determine if AD109 (aroxybutynin + atomoxetine) is a viable option as an oral treatment for OSA. Enrollment for the clinical trials is expected to begin in the second quarter of 2023, pending discussions with the US Food and Drug Administration.
“There is a tremendous unmet clinical need for new pharmaceutical treatment options for OSA, and this funding recognizes that need and the unique opportunity for AD109 to change the treatment paradigm for this serious disorder,” says Larry Miller, MD, CEO for Apnimed, in a release. “With this funding, Apnimed can move forward with the late-stage clinical trials that will form the basis for approval of AD109.”
The drug targets key neurological pathways in OSA that activate upper airway dilator muscles to keep the airway open during sleep. AD109 is designed to treat airway obstruction at night and improve daytime consequences of OSA, such as fatigue. It has the potential to treat patients across a broad spectrum of disease severity.
The FDA has granted AD109 Fast Track designation.
The additional money was secured in an oversubscribed financing round that extends Apnimed’s Series C financing, bringing total funding to $142.75 million. Financing was led by existing investor Alpha Wave Ventures and included existing investors Sectoral Asset Management, Columbia-Seligman Investments, and Tao Capital Partners.
“The results of the phase 2 MARIPOSA study were highly promising and informed the design of the two phase 3 trials to identify those patients who could benefit from a new oral treatment,” says Chris Dimitropoulos, managing director of Alpha Wave Ventures, in a release. “We’re excited to lead this financing, which will allow Apnimed to conduct its registration phase 3 trials for this important alternative for the large number of patients with OSA who are unable to tolerate current therapies.”