Pliant Therapeutics (NASDAQ:PLRX) reported 12-week interim data for its drug bexotegrast’s 320 mg dose group in a phase 2a trial to treat patients with a type of lung disease called idiopathic pulmonary fibrosis (IPF).
The study, dubbed, INTEGRIS-IPF, is evaluating bexotegrast (PLN-74809) at once-daily doses of 40 mg, 80 mg, 160 mg, 320 mg or placebo for 12 weeks in 119 patients with IPF — a condition in which the lungs become scarred and breathing becomes difficult.
The 320 mg group enrolled 21 patients in the active arm and 8 patients in the placebo group.
The company said the 320 mg group met its main and secondary goals of showing that bexotegrast was well tolerated over the 12-week treatment period and displayed a favorable pharmacokinetic profile.
The trial’s efficacy goals assessed changes in forced vital capacity (FVC), Quantitative Lung Fibrosis (QLF) imaging and biomarkers.
The 320 mg dose showed a statistically significant mean increase in FVC from baseline at all timepoints, surpassing all lower dose groups, and showed a strong treatment effect on FVC percent predicted (FVCpp), QLF and profibrotic biomarkers versus placebo at 12 weeks, the company added.
Comparable to the lower dose groups, ~80% of all enrolled patients were on standard of care and were equally distributed between nintedanib and pirfenidone, according to the company.
Pliant noted that a strong dose-dependent treatment effect was seen in the bexotegrast 320 mg dose group, with and without standard of care therapy.
Bexotegrast 320 mg was well tolerated and there were no drug-related severe or serious adverse events. The company added that all drug-related adverse events were mild or moderate in severity.
Bexotegrast exhibited dose-proportional increases in plasma concentrations, consistent with prior studies, the company noted.
“Data from the INTEGRIS-IPF trial have far exceeded our expectations, supporting bexotegrast’s favorable safety profile and demonstrating a statistically significant treatment response on FVC at 320 mg,” said Pliant’s Chief Medical Officer Éric Lefebvre.
The company expects data from the 320 mg group for at least 24 weeks of treatment in Q2 2023. Pliant is planning to start a phase 2b trial of bexotegrast in mid-2023.
PLRX +48.02% to $33.32 premarket Jan. 23