Shares of Pliant Therapeutics, Inc. (PLRX) were gaining more than 4% in the pre-market activity on the Nasdaq on Monday after the company announced positive 24-week data Phase 2a clinical trial INTEGRIS-PSC of bexotegrast in patients with primary sclerosing cholangitis or PSC.
The data was from the 320 mg cohort of INTEGRIS-PSC, a multinational, randomized, double-blind, placebo-controlled Phase 2a clinical trial of bexotegrast in patients with PSC and suspected moderate to severe liver fibrosis.
The primary endpoint of the trial was the evaluation of the safety and tolerability of bexotegrast.
In the trial, the 320 mg treatment group met its primary endpoint of safety, demonstrating that bexotegrast was well tolerated up to 40 weeks of treatment with no treatment-related severe or serious adverse events. Pruritus and cholangitis occurred in lower proportions on bexotegrast than on placebo, consistent with previous findings.
The exploratory endpoints of the INTEGRIS-PSC trial included changes in liver stiffness as measured by transient elastography at 24 weeks, changes in liver fibrosis markers including ELF, liver biochemistry and MRI imaging. These data suggest stabilization of liver fibrosis.
Éric Lefebvre, Chief Medical Officer of Pliant, said, "These longer term INTEGRIS-PSC data continue to highlight bexotegrast's favorable safety and tolerability profile, further validate its broad antifibrotic activity in diseases of unmet need and suggest the potential for disease stabilization. Furthermore, these positive data provide additional confidence in our IPF development program centered on BEACON-IPF, our ongoing global Phase 2b/3 trial."
In the pre-marlet activity on the Nasdaq, Pliant shares were trading at $13.31, up 4.4 percent.
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