Pliant Therapeutics, Inc. (NASDAQ: PLRX) has released positive long-term data from the INTEGRIS-PSC Phase 2a trial, demonstrating the favorable safety and tolerability profile of bexotegrast at a dosage of 320 mg. The multinational, randomized, double-blind, placebo-controlled trial involved 121 patients with primary sclerosing cholangitis (PSC) and suspected moderate to severe liver fibrosis.
The 320 mg treatment group met its primary endpoint of safety, with bexotegrast being well tolerated up to 40 weeks of treatment. Notably, there were no treatment-related severe or serious adverse events reported in this cohort. The trial's exploratory efficacy endpoints showed significant improvements in liver stiffness, alkaline phosphatase (ALP) levels, hepatocyte function, and bile flow when compared to the placebo group.
Specifically, bexotegrast at 320 mg demonstrated a statistically significant improvement in liver stiffness at week 24 compared to placebo. There was also a notable reduction in ALP levels over 24 weeks compared to an increase observed in the placebo group. MRI imaging indicated further improvement in hepatocyte function and bile flow with bexotegrast at the 320 mg dose from week 12 to 24.
The data also revealed that bexotegrast-treated patients displayed a stable score on the itch numerical rating scale relative to a numerical increase on placebo, indicating an improvement in symptoms of cholestasis. Additionally, adverse events of pruritus and cholangitis occurred in a lower proportion of bexotegrast-treated patients at 320 mg compared to those on placebo.
Dr. Éric Lefebvre, Chief Medical Officer of Pliant, expressed satisfaction with the study's results, emphasizing the favorable safety profile and broad antifibrotic activity of bexotegrast in diseases of unmet need. He also highlighted the potential for disease stabilization.
The positive data from the INTEGRIS-PSC trial have provided additional confidence in Pliant's IPF development program centered on Beacon-IPF, an ongoing global Phase 2b/3 trial. The company conducted a meeting with the U.S. Food and Drug Administration (FDA), and the FDA expressed support for a 52-week, dose-ranging Phase 2b trial employing non-invasive endpoints, indicating a promising path forward for the development of bexotegrast in PSC.
PSC is a rare, progressive liver disease with no approved therapies, presenting a high unmet need for new treatment options. Pliant's lead product candidate, bexotegrast (PLN-74809), has received fast track designation and orphan drug designation from the FDA in both IPF and PSC, as well as orphan drug designation from the European Medicines Agency in IPF and PSC.
The company's commitment to addressing fibrotic diseases also extends to other therapeutic areas, as evidenced by its ongoing development programs for the treatment of solid tumors and muscular dystrophies.
Pliant Therapeutics continues to make significant strides in its efforts to advance potential treatments for challenging and underserved medical conditions, as demonstrated by the promising outcomes of the INTEGRIS-PSC trial. As a result of these announcements, the company's shares have moved 3.8% on the market, and are now trading at a price of $13.24. Check out the company's full 8-K submission here.
