On July 15, 2024, Pliant Therapeutics announced positive results from their Phase 2a INTEGRIS-PSC trial for bexotegrast in treatment of PSC. In this randomized controlled study of bexotegrast, the 320 mg arm showed the following key findings (as stated by the sponsor):
The 320 mg cohort demonstrated improvement in liver stiffness by transient elastography at Week 24 compared to placebo
Statistically significant improvement observed in alkaline phosphatase (ALP) levels over 24 weeks compared to increased levels on placebo
Continued improvement in hepatocyte function and bile flow by contrast MRI imaging was observed from Week 12 to Week 24
FDA guidance provided clarity on next steps of PSC development program
Bexotegrast at 320 mg was well tolerated up to 40 weeks of treatment with no treatment-related severe or serious adverse events
The 320 mg cohort demonstrated improvement in liver stiffness by transient elastography at Week 24 compared to placebo
Statistically significant improvement observed in alkaline phosphatase (ALP) levels over 24 weeks compared to increased levels on placebo
Continued improvement in hepatocyte function and bile flow by contrast MRI imaging was observed from Week 12 to Week 24
FDA guidance provided clarity on next steps of PSC development program
This news comes as a follow-up to the preliminary results at 12 weeks from the same INTEGRIS-PSC trial. This marks the completion of the Phase 2a trial; the Registry will continue to provide updates as more information becomes available.
Thank you to everyone who has participated in this trial and all clinical trials! More information about all PSC clinical trials can be found on the PSC Partners Patient Registry website.