Drug Details

Avalyn has reformulated pirfenidone for inhaled aerosol lung delivery via an approved handheld eFlow® vibrating membrane nebulizer. This aerosolized formulation allows small inhaled doses to be delivered as a soft mist directly to the lung, maximizing pirfenidone’s lung dose and effect on diseased lung tissue while sparing tissue outside the lungs from oral-associated drug levels.

Study Purpose

This is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 versus placebo on top of standard of care in participants with PPF over 52 weeks.

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