Pliant Therapeutics Reports Positive Long-Term Data from Phase 2a IPF Study
May 2, 2023
Rare Daily Staff
Pliant Therapeutics reported positive results from 24-week data from the 320 mg dose group of INTEGRIS-IPF, a multinational, randomized, dose-ranging, double-blind, placebo-controlled phase 2a clinical trial of its experimental therapy bexotegrast in patients with idiopathic pulmonary fibrosis.
The 320 mg dose group met its primary and secondary endpoints demonstrating that bexotegrast displayed a favorable pharmacokinetic profile. The trial’s exploratory efficacy endpoints assessed changes in forced vital capacity (FVC), Quantitative Lung Fibrosis (QLF) imaging, patient reported cough severity and biomarkers. At Week 24, bexotegrast-treated patients demonstrated improvements across all of these exploratory efficacy endpoints versus placebo.
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.
Pliant’s lead product candidate, bexotegrast, is an oral, small molecule, dual-selective inhibitor of αvβ6 and αvβ1 being developed for the treatment of IPF and primary sclerosing cholangitis.
INTEGRIS-IPF was a phase 2a, multinational, randomized, dose-ranging, double-blind, placebo-controlled trial evaluating the safety, tolerability, and pharmacokinetics of bexotegrast administered in patients with IPF. The 320 mg group enrolled 21 patients in the active arm and 8 patients in the placebo arm. Comparable to the lower dose groups, approximately 80 percent of enrolled patients were on standard of care and were equally distributed between nintedanib and pirfenidone.
The primary endpoint of the INTEGRIS-IPF trial was the evaluation of the safety and tolerability of bexotegrast. Bexotegrast was well tolerated at 320 mg up to 40 weeks of treatment with no drug-related serious adverse events (SAE) reported. Most frequently reported treatment-emergent adverse events (TEAE) were mild or moderate in severity and not related to study drug. No TEAE-related discontinuations occurred after Week 12.
“These data build on our previously reported results and highlight a favorable long-term safety profile and provide further evidence of a durable improvement in FVC, the registrational endpoint in IPF,” said Éric Lefebvre, chief medical officer at Pliant Therapeutics. “The INTEGRIS-IPF data provides us with confidence as we move into late-stage development.”
Photo: Éric Lefebvre, chief medical officer at Pliant Therapeutics
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