Avalyn Raises $35.5M to Support Trials of Inhaled Pirfenidone for IPF, CLAD

Avalyn Pharma announced that it has raised $35.5 million in Series B funding to expand its pipeline and support clinical trials into AP01, its investigational inhalation treatment for idiopathic pulmonary fibrosis (IPF) and chronic lung allograft dysfunction (CLAD).

The company also reported recently completing enrollment for a clinical study into two dosing regimens of AP01 in people with IPF.

A Phase 1 study of APO1, conduced in Australia (ANZCTRN 12617001501336),  found the treatment — an inhalation form of pirfenidone — to be safe and well-tolerated at a 12.5 mg/mL dose in a group of 38 healthy volunteers that included current and former smokers, and six IPF patients. APO1 was delivered using the investigational eFlow Nebulizer System by Pari Pharma.

Avalyn  also plans to launch a Phase 2/3 trial investigating AP01 for CLAD, the most common form of transplant rejection reported to occur within five years in about half of all patients given a lung transplant.

Part of the funding will support a Phase 1 trial on another experimental therapy, called AP02, that has shown promise in animal models of lung injury.

AP01 is an aerosolized form of pirfenidone (sold under the brand name Esbriet by Genentech), while AP02 is an aerosolized form of nintedanib (sold under the brand name Ofev by Boehringer Ingelheim).

Esbriet and Ofev are both oral anti-fibrotic medications approved to reduce lung tissue scarring, or fibrosis, in IPF patients.

In contrast to these oral treatments, AP01 and AP02 are designed to be inhaled directly into the lungs. This new formulation is expected to  boost the medication’s efficacy, and to result in fewer side effects as it is taken in “small inhaled doses delivered directly to the lung,” the company reports on a webpage.

“Reformulating systemic drugs for targeted inhaled lung delivery has successfully improved the efficacy and decreased systemic adverse effects of corticosteroids and bronchodilators in both asthma and COPD, and of antibiotics in cystic fibrosis,” A. Bruce Montgomery, MD, CEO of Avalyn Pharma, said in press release.

“Despite the 2014 approval of two oral antifibrotic therapies, IPF and other fibrotic lung diseases remain fatal diseases with substantial unmet needs. We hope to accomplish improved tolerability and efficacy with both aerosolized pirfenidone and nintedanib. We are pleased by the safety profile we have seen to date with aerosolized pirfenidone in nearly 100 patients,” he added.

The financing was led by Norwest Venture Partners, along with new investor Pivotal bioVenture Partners and current investors F-Prime Capital, Novo Holdings A/S, RiverVest Venture Partners, and TPG Biotech.

More information on the recently enrolled trial of APO1 in IPF patients was not available.