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A treatment effect was observed in all PLN-74809 dose groups, with and without standard of care therapy. A pooled analysis of PLN-74809 treated patients showed an 80% reduction in FVC decline at 12 weeks versus placebo (-15.1 mL for PLN-74809 pooled groups versus -74.1 mL for placebo). The 40 mg and 160 mg dose groups demonstrated 38% (-46.1 mL) and 66% (-25.1 mL) reductions in FVC decline relative to placebo, respectively. Importantly, in the 80 mg treatment group, a +24.6 mL increase in FVC was observed relative to baseline.

A dose-dependent reduction in the proportion of patients with FVCpp decline of ≥10% was observed across treatment groups: 18.2%, 8.7% and 4.5% of patients experienced a ≥10% decline in FVCpp in the 40 mg, 80 mg and 160 mg treatment groups, respectively, versus 17.4% in the placebo group. A decline of ≥10% in percent predicted FVC (FVCpp) at 12 weeks is associated with an increased risk of death in IPF patients over a two-year period.1

An increase in QLF score is associated with an increase in pulmonary fibrosis. The mean percentage change in QLF at 12 weeks was 3.15%, 0.70% and 0.00% in the 40 mg, 80 mg and 160 mg treatment groups, respectively, versus 1.15% in the placebo group. These findings suggest a dose-dependent antifibrotic effect of PLN-74809, consistent with its mechanism of action and preclinical findings.

“Data from the INTEGRIS-IPF trial exceeded our expectations exhibiting a favorable safety and tolerability profile and a treatment effect on FVC, the current registrational endpoint in IPF. Importantly, the treatment effect was also observed on top of standard of care therapy,” said Éric Lefebvre, M.D., Chief Medical Offer at Pliant Therapeutics. “Additionally, the dose-dependent reduction observed in the proportion of patients experiencing a decline in percent predicted FVC of ≥10% underscores the potential of this novel investigational therapy to advance the treatment of IPF.”

“I am very encouraged by the Phase 2 results from INTEGRIS-IPF. IPF studies are challenging, as large samples sizes are usually required to detect a treatment effect,” said Lisa H. Lancaster, M.D., Professor of Medicine, Vanderbilt School of Medicine and INTEGRIS-IPF Principal Investigator. “The results from INTEGRIS-IPF are impressive, with PLN-74809 demonstrating a favorable safety profile and treatment effect both on and off standard of care therapy. The IPF patient community is in desperate need of new drugs given the limited treatment options currently available.”

INTEGRIS-IPF Next Steps

Pliant has recently completed enrollment in the 320 mg cohort of the INTEGRIS-IPF Phase 2a trial. The 12 week interim data from the 320 mg cohort is anticipated in early 2023. Today’s data is intended to be shared with regulatory authorities in the near term to discuss the late-stage development of PLN-74809.

We would like to thank our INTEGRIS-IPF investigators and their study teams as well as the members of the Pliant team for their dedication in support of the successful execution of this trial.Special thanks to the INTEGRIS-IPF clinical trial participants, their families and support networks for helping us advance this promising program.

INTEGRIS-IPF Multinational Phase 2 Trial of PLN-74809 (NCT04396756)

INTEGRIS-IPF is a Phase 2a, randomized, dose-ranging, double-blind, placebo-controlled trial evaluating the safety, tolerability, and pharmacokinetics of PLN-74809 administered over 12 weeks in patients with IPF. Patients were enrolled in doses of 40 mg, 80 mg, 160 mg or 320 mg, with a 3:1 randomization ratio (active:placebo) and stratification based on use of standard of care therapy. The primary endpoint is the evaluation of PLN-74809 safety and tolerability and the secondary endpoint is the assessment of pharmacokinetics across a dose range. Exploratory endpoints will measure change in Forced Vital Capacity (FVC), HRCT-based Quantitative Lung Fibrosis (QLF) score and selected biomarkers.

Background on Idiopathic Pulmonary Fibrosis

IPF is a chronic, progressive, fibrosing lung disease of unknown cause with few treatment options and a poor prognosis. Patients experience debilitating symptoms, including shortness of breath and difficulty performing daily activities, such as walking and talking. Currently, there is no pharmacological cure for IPF with neither of the approved two therapies demonstrating an ability to stop the progression of IPF. Therefore, there is a high unmet need for new therapeutic options to address the symptoms and modify the disease progression of this grievous illness.

Conference Call and Webcast

The Company will host a conference call and webcast with a slide presentation tomorrow, Monday, July 11 at 8:00 a.m. ET to discuss this update. Interested parties may access the conference call live via webcast on Pliant’s website at https://edge.media-server.com/mmc/p/5rrtxipc or may participate via telephone by registering using this online form. Upon registration, all telephone participants will receive the dial-in number along with a unique PIN number that can be used to access the call. A replay of the conference call webcast will be available in the Events & Presentations section of the Investors & Media page of the Pliant website for 30 days following completion of the event.