Avalyn Pharma has announced the initiation of the Phase 2b MIST study of AP01 pirfenidone inhalation solution in patients with progressive pulmonary fibrosis (PPF). In March 2023, the company announced that a Phase 1b trial of nebulized AP01 in IPF patients demonstrated a significant reduction in the progression of the disease, with lung function in most patients basically stabilized. The year-long Phase 2b trial is expected to enroll 300 PFF patients and will compare 2 dose levels of AP01 to placebo.
In addition to AP01, Avalyn is developing AP02 inhaled nintedanib for the treatment of pulmonary fibrosis and recently initiated a Phase 1b trial of AP02 in healthy adults. According to the company’s web site, Avalyn also intends to develop an inhaled fixed dose combination of nintedanib and pirfenidone.
Avalyn CEO Lyn Baranowski commented, “We are thrilled to start this Phase 2b study of AP01, which marks another significant milestone for Avalyn and our commitment to advancing inhaled treatments for patients with pulmonary fibrosis. We are encouraged by AP01’s robust clinical data generated to date, which demonstrated strong tolerability and efficacy with inhaled delivery of pirfenidone. We would like to extend our sincere gratitude to the pulmonary fibrosis community of health care practitioners, patients, and their caregivers for their ongoing support of our efforts to develop an innovative therapeutic option for people living this life-threatening disease.”
Read the Avalyn Pharma press release.
