Pliant Therapeutics Announces Positive DSMB Safety Review and Commencement of Enrollment of Phase 2a Trial of PLN-74809 at 320 mg Dose in Idiopathic Pulmonary Fibrosis

Recent independent Data Safety Monitoring Board (DSMB) review recommended the INTEGRIS-IPF Phase 2a trial continue without modification and proceed to evaluate dosing at 320mg

Trial initiation follows the FDA authorization of evaluation of long-term dosing of PLN-74809 at doses up to 320 mg in IPF patients

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif., Feb. 24, 2022 (GLOBE NEWSWIRE) — Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis, today announced that, following a positive independent Data Safety Monitoring Board (DSMB) safety review, enrollment has commenced in a Phase 2a trial of PLN-74809 at 320 mg dosed once daily for at least six months in patients with idiopathic pulmonary fibrosis (IPF). PLN-74809, is an oral, small molecule, dual-selective inhibitor of αvβ6 and αvβ1 being developed for the treatment of IPF and primary sclerosing cholangitis (PSC). PLN-74809 has been administered to over 450 study participants, including healthy volunteers and patients, with no drug-related serious adverse events or drug-related severe adverse advents reported to date.

“We are pleased that the favorable safety and tolerability profile seen with PLN-74809 to date supports the advancement of our Phase 2a program to evaluate a higher dose at a longer treatment duration,” said Bernard Coulie M.D. Ph.D., President and CEO of Pliant. “It is noteworthy that our sub-chronic and chronic GLP toxicology studies have revealed no on-target or off-target safety concerns across all doses tested. Moreover, throughout Phase 1 and Phase 2 trials, PLN-74809 has been well tolerated with no drug-related safety concerns identified to date.”

About the Phase 2a Trial

This Phase 2a trial is a randomized, double-blind, placebo-controlled study evaluating PLN-74809 at 320 mg administered daily over at least six months, and up to 48 weeks, in approximately 28 patients with IPF. The primary endpoint is the evaluation of PLN-74809 safety and tolerability and the secondary endpoint is the assessment of pharmacokinetics. Exploratory endpoints will measure change in forced vital capacity (FVC), HRCT-based Quantitative Lung Fibrosis score (QLF), and selected biomarkers over 6 months of treatment.

This trial is leveraging the same sites and protocol as the INTEGRIS-IPF Phase 2a trial, which recently competed enrollment at doses of 40 mg, 80 mg and 160 mg. Topline data from the INTEGRIS-IPF trial is expected to be released in mid-2022.

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