Pliant Therapeutics has announced positive long-term data from its INTEGRIS-PSC clinical trial.

Participants in this trial were randomly selected to either have the treatment drug or a placebo (dummy drug). If you were one of those participants, thank you for helping us understand more about PSC and how to treat it.

Early results were released in September last year, suggesting that the treatment drug, (bexotegrast, also known as PLN-74809) showed promising signs of reducing scarring in the liver, improving liver blood tests and improving the appearance of the liver in scans at lower doses.

Today's announcement was about the high dose treatment group (320mg). Pliant reported that bexotegrast was well tolerated up to 40 weeks of treatment and that it improved liver blood tests (alkaline phosphatase), the appearance of the liver in MRI scans, self-reported itch, and cholangitis episodes compared to the placebo group. They also reported reductions in liver stiffness (a marker of liver fibrosis measured by transient elastography).

Professor Gideon Hirschfield, FRCP, Ph.D., Lily and Terry Horner Chair in Autoimmune Liver Disease at the University of Toronto and a principal investigator in the INTEGRIS-PSC trial.said, “I continue to be encouraged by the consistent safety and efficacy trends seen with these data that clearly align with the data previously presented. These data, alongside those from bexotegrast in IPF, suggest a strong clinical antifibrotic effect across multiple diseases. Today’s PSC data is further strengthened with the new transient elastography data in liver stiffness.”

What's next?

Pliant is considering a 52-week Phase 2b trial of bexotegrast, and is looking at non-invasive ways to measure how effective the drug is.