Avalyn Pharma Inc. (NASDAQ:AVLN) saw its stock rise 3.5% on Wednesday following an announcement that the company achieved its target enrollment in the Phase 2b trial of AP01, an investigational inhaled pirfenidone therapy for progressive pulmonary fibrosis.
The company said the MIST trial enrolled 375 patients, meeting the enrollment goal ahead of schedule. Avalyn indicated it expects to release topline clinical results at the 12-month point in the second half of 2027.
MIST is being conducted as a global, randomized, double-blinded, placebo-controlled Phase 2b study designed to assess safety and efficacy across two dose levels of AP01. According to the company, the trial randomized patients in a 2:1:2 ratio into three groups: AP01 100 mg twice-daily, AP01 50 mg twice-daily, and placebo. The study's primary endpoint is the change from baseline in lung function, as measured by forced vital capacity, at 52 weeks.
Progressive pulmonary fibrosis is described by the company as a serious, degenerative condition that results in declining lung function. Avalyn noted that median survival after diagnosis with current treatments ranges from three to five years.
In comments included with the announcement, Chief Executive Officer Lyn Baranowski attributed the faster-than-expected enrollment to strong engagement from investigators and patients. The company also pointed to data from its earlier ATLAS Phase 1b trial and an ongoing open-label extension study, which it said suggest AP01's tolerability profile may allow patients to remain on treatment for longer periods.
Clinical and market context
The MIST trial's design - randomized, double-blinded and placebo-controlled - aims to evaluate both safety and efficacy across two active dose arms against placebo, with forced vital capacity at one year serving as the principal measure of lung function change. The company has set a timeline to disclose topline results at the 12-month assessment in the second half of 2027.
What the company reported
- Avalyn completed enrollment of 375 patients in the MIST Phase 2b trial ahead of schedule.
- The trial randomized participants 2:1:2 into AP01 100 mg twice-daily, AP01 50 mg twice-daily, and placebo cohorts.
- Topline 12-month data are expected in the second half of 2027.
Stock reaction
Following the enrollment update, Avalyn shares rose 3.5% on Wednesday. The company name and ticker were included in the announcement: Avalyn Pharma Inc. (NASDAQ:AVLN).
Ongoing evidence referenced by the company
Avalyn referenced data from its ATLAS Phase 1b study and the ongoing open-label extension as supporting the view that AP01's tolerability profile could help patients stay on therapy longer, a point the company presented as relevant to the investigational therapy's clinical profile.