ZhongSheng Pharmaceutical has announced positive topline results from a Phase IIb trial of its PDE inhibitor, ZSP1601, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). The study met its primary endpoint, with 64.9% and 57.6% of patients in the 100 mg and 50 mg twice-daily dose groups achieving a histological response at 48 weeks, compared to 32.5% in the placebo group. The drug also demonstrated significant improvements in key fibrosis and liver fat content measures, indicating potential to reverse liver fibrosis.

The company plans to advance ZSP1601 into pivotal Phase III trials based on these results. The candidate, designated a National Major New Drug Innovation project in China, was well-tolerated with a safety profile comparable to placebo. The data position ZSP1601 as a promising oral therapy in the competitive MASH landscape, with a mechanism distinct from currently approved treatments.

PharmCube's NextBiopharm® database shows that ZSP1601 is poised to challenge two PDE inhibitors in the market, as it is the most advanced clinical-stage candidate under active development. Click here to request a free trial for NextBiopharm®.