Pliant Therapeutics Inc (NASDAQ: PLRX) has announced 12-week interim data from the 320 mg dose group of INTEGRIS-IPF Phase 2a clinical trial of bexotegrast (PLN-74809) in patients with idiopathic pulmonary fibrosis (IPF).
The 320 mg group met its primary and secondary endpoints demonstrating that bexotegrast was well tolerated over a 12-week treatment period and displayed a favorable pharmacokinetic profile.
Bexotegrast at 320 mg demonstrated a statistically significant mean increase in forced vital capacity from baseline at all time points, surpassing all lower dose cohorts.
It also showed a strong treatment effect on FVC percent predicted (FVCpp), quality of life, and profibrotic biomarkers versus placebo at 12 weeks.
The 320 mg group will continue until all patients have been treated for at least 24 weeks, with final data expected in the second quarter of 2023.
Pliant plans to initiate a Phase 2b clinical trial of bexotegrast in mid-2023. Trial details will be shared closer to initiation.
The company reported lower dose results from the Phase 2 trial, demonstrating that the 40 mg and 160 mg dose groups showed 38% and 66% reductions in FVC decline relative to placebo, respectively.
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