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Pliant Therapeutics Announces Positive Data from Expanded Phase 1b BAL Trial of PLN-74809 Demonstrated Suppression of TGF-β Signaling in Healthy Volunteers
At all dose levels, PLN-74809 demonstrated durable pSmad suppression relative to placebo at 6 hours and 24 hoursTGF-β suppression of up to 92% and 76% from
About this update from Pliant Therapeutics, Inc.
[{"type":"text","content":"At all dose levels, PLN-74809 demonstrated durable pSmad suppression relative to placebo at 6 hours and 24 hoursTGF-β suppression of up to 92% and 76% from baseline at 6 and 24 hours, respectively PLN-74809 was well tolerated with no serious or severe adverse events SOUTH SAN FRANCISCO, Calif., Feb. 28, 2022 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced positive data from its expanded PLN-74809 Phase 1b proof-of-mechanism trial. PLN-74809 demonstrated clear evidence of on-target biological activity in the lungs of healthy participants. Results showed that PLN-74809 inhibited TGF-β activation on Day 7 by up to 92% and 76% at 6- and 24-hours, respectively, following dosing. TGF-β has been shown to be a key mediator of the fibrosis pathway in idiopathic pulmonary fibrosis (IPF). “Today’s data expand upon previous results providing evidence of PLN-74809’s ability to inhibit activation of TGF-β, a key molecular driver of fibrosis, in the lungs of healthy volunteers. We believe that by inhibiting this critical component, PLN-74809 may disrupt the fibrosis pathway and affect disease progression in patients with IPF,” said Éric Lefebvre, M.D., Chief Medical Officer at Pliant Therapeutics. “All of our preclinical and clinical proof-of-mechanism studies have been designed to build a comprehensive understanding of the potential antifibrotic activity of PLN-74809 across its full dose range. We are pleased to see that our research and data continue to provide evidence of a favorable safety, tolerability and pharmacokinetic profile. We believe these data provide additional de-risking of our ongoing Phase 2a INTEGRIS-IPF trial and future development programs.” Expanded Phase 1b Proof of Mechanism Trial of PLN-74809 The randomized, double-blind, placebo-controlled Phase 1b trial evaluated PLN-74809’s ability to suppress TGF-β after 7 days of dosing in 36 healthy volunteers. The trial was conducted in two parts. Part 1 evaluated PLN-74809 at doses of 80 mg and 160 mg once-daily versus placebo and Part 2 evaluated PLN-74809 at a dose of 320 mg once-daily versus placebo. In addition to safety and pharmacokinetics, the trial evaluated PLN-74809's ability to suppress TGF-β activation in the lungs of healthy volunteers as measured through relative pSmad2 levels in alveolar macrophages collected through bronchioalveolar ...