Sponsoring company: Avalyn Pharma
Disease state: progressive pulmonary fibrosis
The MIST PPF Study is a global phase 2b clinical research study to evaluate the safety and efficacy of AP01 (inhaled pirfenidone) in patients with progressive pulmonary fibrosis (PPF). This randomized, double-blind, placebo-controlled study is expected to enroll approximately 300 individuals with PPF across North America, South America, Europe, and Asia-Pacific.
The primary endpoint of the study is change from baseline in forced vital capacity (FVC) at week 52. Secondary endpoints include quality of life measurements, time to disease progression, and change in lung fibrosis score based on high-resolution computed tomography (HRCT). Additional exploratory outcomes will also be evaluated.
This clinical research study is for adults age 18 and older with PPF, who show worsening symptoms and/or decline in lung function. Patients can be on background immunosuppressants or oral nintedanib.
CLINICALTRIALS.GOV LINK »
STUDY LINK »