Genoa Secures $62 Million to Fund Phase 2 Trial of Inhaled Aerodyne for Idiopathic Pulmonary Fibrosis

Genoa Pharmaceuticals has completed a $62 million Series A financing round to pursue a Phase 2 clinical trial of Aerodone (inhaled pirfenidone) to treat idiopathic pulmonary fibrosis (IPF).

The Seattle-based company also appointed Dr. Ketan Patel, Dr. Naveed Siddiqi, Tiba Aynechi, Niall O’Donnell and Dr. Heather Preston to its board of directors. Dr. Jonathan Leff, who led the development and approval of Esbriet (oral pirfenidone) was named an independent director.

In addition, it has appointed Dr. Bruce Montgomery as CEO; he will spearhead Aerodone’s clinical development out of the Seattle office. Founder and inventor Mark Surber was named chief scientific officer and will focus on nonclinical support and pipeline R&D from Genoa’s San Diego office.

Esbriet is an oral antifibrotic medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of IPF, an orphan lung disease that causes progressive lung scarring, reduced exercise capacity and ultimately death from respiratory failure or co-morbidities. Esbriet has been shown to slow IPF disease progression. However, it is a low-potency drug that requires a large dose, thus causing adverse side effects.

Genoa developed Aerodone as an inhaled formulation of pirfenidone in order to increase the amount of drug that enters the lungs without the side effects caused by Esbriet.

“In addition to advancing our early-stage pipeline, with this financing and our veteran development team, we have the funds and expertise to test Aerodone for the treatment of IPF through Phase 2 clinical trials,” Surber said in a press release. “Despite the approval of two medicines, IPF remains a fatal disease with substantial unmet need for improved tolerability and effective medical treatments. By the inhaled approach, we are enthusiastic for the opportunity to meet these needs and improve patient lives.”

According to Genoa, Aerodone is on track to enter clinical development by year’s end.

“Reformulating systemic drugs for targeted inhaled lung delivery has successfully improved the efficacy and decreased systemic adverse effects for corticosteroids and bronchodilators in both asthma and COPD, and antibiotics in cystic fibrosis,” said Montgomery. “We hope to accomplish the same benefits with pirfenidone.”