Benzinga -
- 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.
- Price Action: PLRX shares are up 55.49% at $35.00 during the premarket session on the last check Monday.