Core Insights - The clinical trial HARMONY for HTD1801 in Type 2 Diabetes Mellitus (T2DM) patients has shown positive results, achieving its primary endpoint and outperforming Dapagliflozin in several key cardiovascular metabolic indicators [1][2] - HTD1801 targets the root causes of T2DM, providing comprehensive cardiovascular metabolic benefits [1] Summary by Sections Clinical Trial Results - HARMONY is a randomized, double-blind, positive drug-controlled Phase III clinical study involving 369 participants, assessing the efficacy and safety of HTD1801 compared to Dapagliflozin in adults with T2DM who have inadequate blood sugar control after Metformin treatment [1] - The primary endpoint was the change in HbA1c from baseline after 24 weeks of treatment, with HTD1801 showing a least squares (LS) mean change of -1.12% compared to -0.93% for Dapagliflozin (LS mean difference: -0.20%; 95% CI: -0.37 to -0.03; P < 0.001) [1] - HTD1801 also achieved multiple secondary endpoints, demonstrating superior reductions in LDL-C and non-HDL-C compared to Dapagliflozin, with a significantly lower proportion of patients requiring additional or intensified statin therapy [1] Safety and Tolerability - HTD1801 exhibited good safety and tolerability, with a serious adverse event rate of 3.8% (compared to 4.4% in the Dapagliflozin group) [2] - The most common adverse events in the HTD1801 group were mild to moderate gastrointestinal issues, with no severe hypoglycemic events reported [2] Future Prospects - HTD1801's ability to simultaneously regulate metabolic and inflammatory pathways positions it as a promising foundational treatment for chronic kidney and metabolic diseases (CKM) [2] - Following the positive outcomes of the SYMPHONY-1 and SYMPHONY-2 trials, HARMONY marks the third successful Phase III trial for HTD1801, reinforcing its potential [2] - The company plans to initiate a New Drug Application (NDA) for HTD1801 within the year [2]
君圣泰医药-B(02511)公布HTD1801与达格列净的头对头III期临床研究结果展现控糖优势及心血管代谢优效获益