- Pliant Therapeutics Inc PLRX shares plunged over 20% Monday after it released longer-term safety, preliminary efficacy data from the INTEGRIS-IPF Phase 2a study of bexotegrast (PLN-74809) in patients with idiopathic pulmonary fibrosis (IPF).
- IPF is marked by scarring of the lung, which makes breathing difficult.
- The 320 mg dose group met its primary and secondary endpoints demonstrating that bexotegrast was well tolerated for up to 40 weeks and displayed a favorable pharmacokinetic profile.
- The INTEGRIS-IPF Phase 2a trial was designed to evaluate bexotegrast at once-daily doses of 40 mg, 80 mg, 160 mg or placebo for 12 weeks and 320 mg or placebo for up to 48 weeks in 119 patients with IPF.
- Also Read: Novartis Takes Down $80M NASH Pact With Pliant Therapeutics.
- At Week 24, bexotegrast-treated patients demonstrated improvements in forced vital capacity (FVC), Quantitative Lung Fibrosis imaging, cough severity, and biomarkers versus placebo.
- 50% of bexotegrast-treated patients experienced an increase in FVC from baseline versus 0% in the placebo group.
- Bexotegrast-treated patients experienced a mean reduction from baseline in FVCpp of 0.8% versus a decline of 2.5% in the placebo-treated group, representing a 68% reduction in decline.
- Bexotegrast-treated participants were more than twice as likely to show stabilization or improvement of fibrosis relative to placebo.
- The company plans to initiate BEACON-IPF, the company's Phase 2b 52-week trial bexotegrast at 160 mg and 320 mg doses in approximately 270 patients with IPF, in mid-2023.
- Price Action: PLRX shares are down 23.7% at $21.53 on the last check Monday.
- Photo Via Company
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