Genoa Pharmaceuticals has raised $62 million to take its lead candidate into the clinic. The Series A sets up new CEO Bruce Montgomery, M.D., to mount a clinical development program designed to establish the inhaled treatment for idiopathic pulmonary fibrosis (IPF) as a rival to products from Boehringer Ingelheim and Roche.
F-Prime Capital Partners and Edmond de Rothschild Investment Partners jointly led the round with support from Novo AS, RiverVest Venture Partners and TPG Biotech. Attracting the support of such heavy hitters has enabled Genoa to put together a Series A round that secures its financial future up to the delivery of critical data on its lead candidate while also allowing it to spend on earlier-stage candidates.
Aerodone is the focal point of the Series A. The candidate is an inhaled formulation of pirfenidone, the active ingredient in Roche’s IPF treatment Esbriet. Roche acquired the drug in its $8.3 billion takeover of InterMune in 2014, shortly before the FDA approved Esbriet. The FDA gave its blessing to Esbriet at the same time as it approved Boehringer’s Ofev. But while those approvals ended the drought in IPF treatment options, Genoa sees them as more of a first step than end point.
“Despite the approval of two medicines, IPF remains a fatal disease with substantial unmet need for improved tolerability and effective medical treatments,” Mark Surber, Ph.D., Genoa founder and CSO, said in a statement. “By the inhaled approach, we are enthusiastic for the opportunity to meet these needs and improve patient lives.”
Surber’s confidence in the inhaled approach is underpinned by a belief it can fix the shortcomings of existing IPF therapies. Patients need a big oral hit of pirfenidone to get enough of the drug into their lungs to improve outcomes. But this leads to high levels of drug in the blood, raising the risk of side effects and capping the maximum dose. By formulating pirfenidone for nebulization and inhaled aerosol delivery, Genoa aims to get more drug into the lungs while minimizing side effects.
Genoa plans to move Aerodone into clinical testing later this year. But Surber, having organized the Series A to support work on his invention, is handing over responsibility for running clinical trials to Montgomery. As CSO, Surber will head up a San Diego office that provides nonclinical support to Aerodone and works on other, earlier-stage pipeline prospects.
Montgomery landed the top job at Genoa on the strength of his record of bringing products, and specifically inhaled drugs, to market. The executive played a major role in the development of a handful of drugs, including Gilead’s Cayston, Roche’s Pulmozyme and Novartis’ TOBI. Montgomery was last seen at Cardeas Pharma trying to turn a $34 million Series B into evidence to support the use of aerosol antibiotics but is better known for work earlier in his career.
In 2006, Montgomery led Corus Pharma to a $365 million takeover by Gilead. Montgomery stuck around at Gilead after the deal, going on to lead the big biotech's 150-person respiratory disease outpost in Seattle, Washington. The Genoa post keeps Montgomery in Seattle, the city in which he established his reputation.