Group 1 - The core finding of the global multicenter Phase IIb clinical trial CENTRICITY (NCT05623189) for HTD1801 in patients with Metabolic Associated Steatotic Liver Disease (MASH) indicates 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, which is significantly higher than the typical placebo effect observed in similar studies [1] - A meta-analysis published in 2025 covering 127 clinical trials for 78 different investigational drugs indicated that the placebo effect in similar trials usually does not exceed 20% [1] Group 2 - Following a review by a third-party organization, issues related to patient medication management and adherence during the trial were identified, which may have significantly impacted the trial results [2] - After excluding abnormal interference factors such as non-compliance with medication protocols, the placebo effect was found to decrease significantly, showing HTD1801 exhibited a trend of therapeutic improvement in several liver histological indicators [2] - The long-term safety and tolerability of HTD1801 in this study were consistent with previous clinical research results, and the company plans to further evaluate the clinical development strategy for HTD1801 in MASH indications based on the overall data and findings from this study [2]
君圣泰医药-B(02511)完成HTD1801治疗代谢相关脂肪性肝炎的 IIb期临床研究