Avalyn Pharma said that idiopathic pulmonary fibrosis (IPF) patients who received the higher dose tested in a Phase 1/2 study of the company’s AP01 pirfenidone inhalation solution “had a trend toward stabilization of lung function,” while those on the lower dose continued a decline in lung function over 24 weeks. As a result, all of the patients who are continuing in a 12-month extension study are now receiving the higher dose.
The trial enrolled 91 patients who received either 50 mg or 100 mg of the inhalation solution delivered via a PARI eFlow nebulizer twice daily. According to Avalyn, fewer than 10% of the patients experienced the types of adverse events that are associated with oral pirfenidone, and AP01 was generally well tolerated at both doses.
Avalyn Pharma CEO A. Bruce Montgomery commented, “We are pleased by the efficacy and safety profile we have seen to date with aerosolized pirfenidone in 91 patients over 24 weeks. The six month FVC data of the high dose is very promising as well as the overall safety profile to date,. Despite the 2014 approval of two oral antifibrotic therapies, IPF and other fibrotic lung diseases remain fatal diseases with substantial unmet need. We hope to establish improved tolerability and long term efficacy with aerosolized pirfenidone in Phase 3 trials to be initiated in 2021.”
Earlier this year, Avalyn announced that it had raised $35.5 million for a Phase 2/3 trial of AP01 for the treatment of chronic lung allograft dysfunction in lung transplant patients. The company is also developing an inhaled formulation of nintedanib.
Read the Avalyn Pharma press release.
