Genoa Pharmaceuticals Secures $62M Series A Financing to Advance Inhaled Pirfenidone (Aerodrone) for Idiopathic Pulmonary Fibrosis

VCBeat (WeChat: vcbeat): Seattle-based biopharmaceutical company Genoa Pharmaceuticals announced the completion of a $62 million Series A financing round, led by F-Prime Capital Partners and Edmond de Rothschild Investment Partners, with participation from Novo AS, RiverVest Venture Partners, TPG Biotech, and others. Including its $2.18 million seed round in 2015, the company’s total funding has now reached $64.18 million. Genoa intends to use these funds to advance its early-stage pipeline and test its [therapy/product] through Phase 2 clinical trials forTreatment of Idiopathic Pulmonary Fibrosis (IPF)of Aerodrone (aerosolized pirfenidone, i.e.Inhaled Pirfenidone) plan.

Genoa Pharmaceuticals Historical Financing Data

Genoa Pharmaceuticals is a biopharmaceutical company dedicated to developing improved therapies for idiopathic pulmonary fibrosis (IPF) and other severe lung diseases. Founded in 2011 and headquartered in Seattle, USA, Genoa’s lead program, Aerodone (inhaled pirfenidone), is scheduled to enter clinical development by the end of the year. The U.S. FDA has granted Aerodone orphan drug designation for the treatment of IPF.

IPF, i.e.Idiopathic Pulmonary Fibrosis, is a chronic, progressive, fibrotic interstitial lung disease with pathology confined to the lungs, predominantly affecting middle-aged and elderly individuals over 50 years old. Similar to scars formed by skin injury, pulmonary fibrosis (PF) constitutes scarring within the lungs. Idiopathic pulmonary fibrosis (IPF), a severe form of PF, can lead to respiratory failure, declined exercise capacity, and ultimately death. Generally, in the absence of lung transplantation, most patients diagnosed with IPF have a survival time of only 2–5 years, with a mortality rate higher than that of most cancers, leading it to be regarded as a “cancer-like disease.”

Therapeutic options for idiopathic pulmonary fibrosis (IPF) are relatively new. In 2014, the first and only approved medications were oral pirfenidone (Esbriet) and oral nintedanib (Ofev). Although these two drugs are effective, they have significant side effects that limit usable dosages and their potential efficacy. While these medications represent an important first step in treating IPF, there remains a substantial unmet need for highly tolerable therapies that can improve outcomes as monotherapies or in combination regimens.

Advantages of the Inhalation Route

Although pirfenidone has shown promise in slowing the progression of idiopathic pulmonary fibrosis (IPF), it is a low-potency drug that requires very high oral doses to achieve therapeutic concentrations in lung tissue. Unfortunately, systemic exposure following oral administration causes significant side effects and limits the deliverable lung dose. To address these shortcomings and maximize the potential of pirfenidone,Genoa has developed a proprietary formulation of pirfenidone (Aerodone) for nebulization and inhalation aerosol delivery.By this method, small inhaled doses delivered directly to the lungs can maximize the efficacy of pirfenidone while avoiding the side effects associated with oral administration.

Dr. Bruce Montgomery, CEO of Genoa Pharmaceuticals, stated that treating IPF requires high-dose medication to achieve a sufficient therapeutic effect on the lungs; however, such high doses may cause side effects in other parts of the body. Direct delivery of the drug to the lungs could mitigate this drawback. He noted, “We can certainly reduce side effects, as our systemic exposure is lowered.”

Concurrent with this financing round, venture capitalists Ketan Patel, Naveed Siddiqi, Tiba Aynechi, Niall O'Donnell, and Heather Preston will join the Board of Directors of Genoa Pharmaceuticals. Mr. Jonathan Leff, former Executive Vice President of Research and Development at InterMune who led the approval process for oral pirfenidone (Esbriet), has been appointed as an Independent Director. Dr. A. Bruce Montgomery has been appointed as CEO and will lead clinical development from the Seattle office. Founder and inventor Dr. Mark Surber, who spearheaded the financing efforts, has been appointed as Chief Scientific Officer. Dr. Surber will oversee the San Diego office, focusing on non-clinical support and pipeline R&D for Aerodone.

Dr. Surber stated, “In addition to advancing our early-stage pipeline, this financing, combined with our experienced development team, provides us with the capital and expertise to evaluate Aerodone in Phase 2 clinical trials for the treatment of IPF. Although two drugs have already been approved, IPF remains a fatal disease, and there is still a significant unmet need for therapies with improved tolerability and efficacy. Through inhalation administration, we have the opportunity to address these needs and improve patients’ quality of life.”

Dr. Montgomery stated, “Reformulating systemic drugs for targeted inhalational pulmonary delivery has successfully enhanced efficacy and reduced the systemic adverse effects of corticosteroids and bronchodilators used in the treatment of asthma and COPD, as well as the side effects of antibiotics used for cystic fibrosis. We aim to modify pirfenidone to achieve similar benefits.”