D&D Pharmatech accelerates licensing after final Phase 2 MASH trial report

D&D Pharmatech (347850.KQ) plans to accelerate global licensing and strategic partnership negotiations after receiving the final clinical study report for its U.S. Phase 2 trial of zavopeglutide (DD01), a treatment for metabolic dysfunction-associated steatohepatitis, or MASH. The report finalized previously disclosed primary endpoint and 48-week biopsy results, with figures unchanged, and confirmed statistically significant benefits in liver fat reduction, fibrosis improvement and MASH resolution. The randomized, double-blind, placebo-controlled trial enrolled 67 overweight or obese patients diagnosed with MASLD or MASH at 12 U.S. sites. At week 12, 75.8% of patients receiving zavopeglutide achieved at least a 30% reduction in liver fat, versus 11.8% for placebo; mean liver fat reduction was 62.3% versus 8.3%. Among 35 patients assessed through paired baseline and week 48 liver biopsies, the 40-milligram treatment arm recorded fibrosis improvement without MASH worsening in 50.0% of patients, compared with 15.8% for placebo, while MASH resolution without fibrosis worsening reached 62.5%, versus 5.3%. Both endpoints were met by 37.5% of treated patients and 5.3% of placebo patients. Benefits in MRI-PDFF liver fat and MRE liver stiffness were maintained through week 48, alongside improvements in body weight, blood glucose and blood lipids. Most adverse events were mild-to-moderate, transient gastrointestinal symptoms, and the company said treatment discontinuation was similar to or lower than competing GLP-1 therapies despite a two-week dose-titration period.

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