Exhibit 99.1
Pliant Therapeutics Announces Positive Safety and Exploratory Efficacy Data
from the INTEGRIS-PSC Phase 2a Trial of Bexotegrast 320 mg in Patients
with Primary Sclerosing Cholangitis and Suspected Liver Fibrosis
Bexotegrast (PLN-74809) at 320 mg was well tolerated over 12 weeks of treatment with
no drug-related severe or serious adverse events; No safety concerns identified across all dose cohorts
Bexotegrast at 320 mg reduced liver fibrosis markers ELF and PRO-C3 and showed improvements in
hepatocyte function and bile flow by contrast MRI imaging relative to placebo at Week 12
The 320 mg data continue to demonstrate antifibrotic effects of bexotegrast,
consistent with previous findings
Company to host webcast and conference call tomorrow, Monday, February 5 at 8:00 a.m. ET
SOUTH SAN FRANCISCO, CA., February 4, 2024 Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced
12-week interim data from the 320 mg dose group of INTEGRIS-PSC, a multinational, randomized, double-blind, placebo-controlled Phase 2a clinical trial of bexotegrast in
patients with primary sclerosing cholangitis (PSC) and suspected moderate to severe liver fibrosis. The 320 mg group met its primary and secondary endpoints demonstrating that bexotegrast was well tolerated over a
12-week treatment period and its plasma concentrations increased with dose. There was no dose relationship for adverse events. Pruritus and cholangitis occurred less frequently on bexotegrast than on placebo.
The trials exploratory efficacy endpoints assessed changes in the liver fibrosis markers, Enhanced Liver Fibrosis (ELF) score and PRO-C3 levels, as well as liver biochemistry and magnetic resonance imaging (MRI) of the liver. Consistent with the results from the lower doses tested, bexotegrast-treated patients at the 320 mg dose showed a
reduction in both ELF score and PRO-C3 levels relative to placebo at Week 12. Bexotegrast-treated patients also showed stabilization of alkaline phosphatase (ALP) levels, relative to an increase on placebo at
Week 12. In addition, MRI imaging continued to show evidence of improved hepatocyte function and bile flow with bexotegrast at the 320 mg dose relative to placebo.
INTEGRIS-PSC is a multinational, randomized, dose-ranging, double-blind, placebo-controlled Phase 2a trial evaluating
bexotegrast at once-daily oral doses of 40 mg, 80 mg, 160 mg, 320 mg or placebo for 12 weeks in 121 patients with PSC. The 320 mg group enrolled 27 patients in the active arm and added 9 new patients to the pooled placebo arm. We believe INTEGRIS-PSC to be the first randomized clinical trial to use an enrichment strategy to enroll patients with suspected moderate to severe liver fibrosis based on liver stiffness measure, ELF score or historical
liver biopsy. Baseline characteristics of the trial population reflected this enrichment. The 320 mg dose group will continue until all patients have been treated for at least 24 weeks, with final data expected in
mid-2024.
Results from INTEGRIS-PSC continue to build on the
favorable safety and tolerability data for bexotegrast which is critically important in the setting of vulnerable patient populations and the need for chronic therapies, said Éric Lefebvre, M.D., Chief Medical Officer of Pliant.
As the therapeutic profile of bexotegrast comes into focus with these data, its encouraging to see bexotegrasts treatment effects manifested across multiple endpoints, suggesting its potential to impact PSC where therapies are
urgently needed. I look forward to additional data from this trial in mid-2024 and upcoming discussions with regulatory authorities surrounding potential next steps.
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