Group 1 - The company announced the completion of a global multicenter Phase IIb clinical study for HTD1801 in patients with Metabolic Associated Steatotic Liver Disease (MASH) [1] - The CENTRICITY trial (NCT05623189) involved 218 patients and aimed to evaluate the efficacy and safety of HTD1801 compared to a placebo in MASH patients with Type 2 Diabetes Mellitus (T2DM) or prediabetes [1] - Preliminary analysis showed that 48% of patients in the placebo group achieved a reduction of ≥2 points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) without fibrosis worsening, significantly higher than previous studies where placebo effects were typically below 20% [1] Group 2 - Following a review by a third-party organization, issues related to patient medication management and adherence were identified, which may have significantly impacted trial results [2] - After excluding these confounding factors, the placebo effect was found to decrease significantly, and HTD1801 showed a trend of therapeutic improvement in several liver histological indicators [2] - The company plans to reassess the clinical development strategy for HTD1801 in MASH based on the overall data, review findings, and post-hoc analysis conclusions, and will communicate with the FDA for further evaluation of the development plan [2]
君圣泰医药-B完成HTD1801治疗代谢相关脂肪性肝炎的 IIb期临床研究