Pliant Therapeutics Inc PLRX released 12-week interim data from the 320 mg dose group of INTEGRIS-PSC Phase 2a trial of bexotegrast in patients with primary sclerosing cholangitis (PSC) and suspected moderate to severe liver fibrosis.
The 320 mg group met its primary and secondary endpoints, demonstrating that bexotegrast was well tolerated over a 12-week treatment period, and its plasma concentrations increased with dose.
There was no dose relationship for adverse events. Pruritus and cholangitis occurred less frequently on bexotegrast than on placebo.
Bexotegrast-treated patients at the 320 mg dose showed a reduction in Enhanced Liver Fibrosis (ELF) score and PRO-C3 levels relative to placebo at Week 12.
Bexotegrast-treated patients also showed stabilization of alkaline phosphatase (ALP) levels relative to an increase on placebo at Week 12.
In addition, MRI imaging continued to show evidence of improved hepatocyte function and bile flow with bexotegrast at the 320 mg dose relative to placebo.
The 320 mg dose group will continue until all patients have been treated for at least 24 weeks, with final data expected in mid-2024.
Bexotegrast at the 320 mg dose was well tolerated, with no dose relationship observed for adverse events.
In September, Pliant Therapeutics announced data from the INTEGRIS-PSC Phase 2a trial of bexotegrast for primary sclerosing cholangitis (PSC) and suspected moderate to severe liver fibrosis.
The trial met its primary and secondary endpoints, demonstrating that bexotegrast was well tolerated over a 12-week treatment period, and its plasma concentrations increased with dose.
The bexotegrast 160 mg dose group demonstrated an 84% reduction of the change in ELF score relative to placebo at Week 12.
Price Action: PLRX shares are down 10.7% at $15.53 on the last check Monday.
Photo via Wikimedia Commons
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.