Pliant Therapeutics, Inc. (NASDAQ: PLRX) is engaged as a clinical-stage biopharmaceutical company, which is focused on the research and development of innovative therapies to treat fibrosis. Shares of the biopharma company are surging 52% through early trading on Monday, January 23, 2023. Over the past three months, Pliant Therapeutics has seen average daily volume of 405,880 shares. However, volume of 7.76 million shares or dollar volume of around $266.79 million, has already exchanged hands through early trading.
Shares of Pliant Therapeutics are rallying after the company announced positive interim data from its INTEGRIS-IPF Phase 2 clinical trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF). The Phase 2 trial is a multi-national, randomized, double-blind, placebo-controlled trial, which was testing a dose of 320 mg of bexotegrast.
After an initial 12-weeks, interim data from the 320 mg dose group met its primary and secondary endpoints, which demonstrated the treatment was well tolerated and provided a favorable pharmacokinetic profile. The trial’s exploratory efficacy endpoints focused on charges in forced vital capacity (FVC), Quantitative Lung Fibrosis (QLF) imaging and biomarkers. At the 320 mg dose, bexotegrast was able to generate a statistically-significant average increase in FVC from the base at all timepoint. This shows the treatment has a strong effect on FVC percent predicted, QLF, and profibrotic biomarkers versus the placebo over the course of twelve weeks.
“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 Éric Lefebvre, M.D., Chief Medical Officer at Pliant Therapeutics. “Additionally, we are extremely encouraged to see a consistent dose response on FVC, QLF and profibrotic biomarkers. We look forward to advancing bexotegrast into Phase 2b clinical development.”
Pilant Therapeutics says it will continue its Phase 2 clinical trial of bexotegrast and the 320 mg dosing group for at least 24 weeks. The next round of clinical data is estimated to be released during the second quarter of 2023. Furthermore, Pilant is planning to launch Phase 2b clinical trial of its drug candidate during mid-2023.
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