Pliant Therapeutics, Inc. provided an update on its PLN-74809 program. In December, the Company completed enrollment of its INTEGRIS-IPF Phase 2a clinical trial in patients with idiopathic pulmonary fibrosis (IPF). INTEGRIS-IPF is a 12-week randomized, dose-ranging, double-blind, placebo-controlled trial evaluating the safety, tolerability, and pharmacokinetics of PLN-74809 at doses of 40, 80 or 160 mg in 84 patients with IPF.

Exploratory endpoints include quantitative lung fibrosis, or QLF, imaging, as well as pulmonary function tests, including forced vital capacity, or FVC. The Company maintains its previous guidance of topline data expected in mid-2022. The U.S. Food and Drug Administration (FDA) has authorized evaluation of long-term dosing of PLN-74809 up to 320 mg in patients with IPF.

PLN-74809 has been administered to over 450 subjects, including healthy volunteers and patients, with no serious adverse events reported to date. This approval enables the evaluation of PLN-74809 in larger, long-term pivotal trials in IPF. Data from a Phase 1b proof of biological mechanism study of PLN-74809 at doses of 80, 160 or 320 mg utilizing bronchoalveolar lavage fluid, or BAL, is expected in the first quarter 2022 Initiation of a 6-month Phase 2a trial of PLN-74809 at 320 mg in IPF is expected in the first half of 2022 INTEGRIS-IPF Phase 2a topline data expected mid-2022 INTEGRIS-PSC Phase 2a trial enrollment expected to complete mid-2022 with topline data expected late 2022 /early 2023 Oncology and muscular dystrophy programs on track with Investigational New Drug (IND) application submissions expected by the end of 2022.