Avalyn Pharma has added on $100 million to accelerate novel inhaled versions of approved drugs for lung conditions.
The company’s series D fundraise was led by Suvretta Capital Management and SR One and included 16 other investors, such as Novo Holdings, the investor fund best known as the controlling shareholder of Novo Nordisk.
The new cash will go toward Avalyn’s clinical programs for pulmonary fibrosis, a lung-scarring condition that makes it harder to breathe.
The Cambridge, Massachusetts-based business touts an inhaled formulation of pirfenidone—sold under many names as a pill for idiopathic pulmonary fibrosis (IPF), such as Pirespa—as one of its two lead programs.
Dubbed AP01, Avalyn is currently assessing the candidate in a global phase 2b study, coded Mist, for patients with progressive pulmonary fibrosis. The trial is expected to enroll 300 participants and has a primary readout slated for April of next year, according to ClinicalTrials.gov.
In an ongoing open-label extension of a phase 1b trial, the inhaled asset demonstrated safety and efficacy for more than four years, according to Avalyn.
The company’s other lead program is another reformulation of an oral medication for IPF called nintedanib, which is marketed as Ofev and Vargatef. Avalyn’s inhaled version is known as AP02 and is expected to enter phase 2 testing for IPF.
“Completing a significant round of financing despite the challenging market conditions is a testament to our innovative approach to developing potentially life-saving medicines for patients with pulmonary fibrosis,” Avalyn CEO Lyn Baranowski said in a July 22 release.
The series D money raise follows a $175 million series C in 2023 and a $35.5 million series B in 2020.
The company hopes its inhaled formulations of approved medicines will be able to reduce systemic exposure and deliver medication directly to the site of disease for pulmonary fibrosis patients.
Avalyn is also advancing AP03, a next-gen inhaled fixed-dose combination of AP01 and AP02. To date, pairing the oral therapies hasn’t been possible because of the additive side effects. Avalyn is currently running preclinical studies for the asset.