Core Viewpoint - The completion of two Phase III clinical trials (SYMPHONY-1 and SYMPHONY-2) for HTD1801 in patients with Type 2 Diabetes Mellitus (T2DM) has shown positive efficacy and safety results over a 52-week period, indicating its potential as a differentiated therapy for T2DM [1][2] Group 1: Clinical Trial Results - The 52-week study results confirm that HTD1801 can modulate metabolism, suppress inflammation, and improve kidney function, offering comprehensive clinical benefits for T2DM patients [2] - SYMPHONY-1 (N=408) and SYMPHONY-2 (N=551) are randomized, double-blind, placebo-controlled trials assessing the efficacy and safety of HTD1801 in T2DM adults with inadequate blood sugar control after dietary and exercise intervention and after metformin treatment, respectively [2][3] - The primary efficacy endpoint was the change in glycated hemoglobin (HbA1c) from baseline after 24 weeks of treatment compared to placebo, followed by a 28-week open-label extension (OLE) phase [2] Group 2: Efficacy Maintenance - In SYMPHONY-1, the HTD1801 treatment group showed a mean HbA1c change of -1.3% at 24 weeks, significantly better than the placebo group, with a stable reduction of -1.2% at 52 weeks [3] - In SYMPHONY-2, the HTD1801 treatment group had a mean HbA1c change of -1.2% at 24 weeks, also significantly better than placebo, with a stable reduction of -1.1% at 52 weeks [3] Group 3: Long-term Benefits - HTD1801 demonstrated sustained benefits in multiple cardiometabolic markers over 52 weeks, including stable HbA1c achievement rates and significant reductions in low-density lipoprotein cholesterol (LDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C) [4] - The treatment also led to a sustained reduction in inflammatory markers such as gamma-glutamyl transferase (GGT) and high-sensitivity C-reactive protein (hs-CRP), which are closely related to cardiovascular events and clinical outcomes in T2DM patients [4] - The estimated glomerular filtration rate (eGFR) remained stable during treatment, with improvements observed in patients with mild renal impairment, indicating HTD1801's potential for renal protection [4] Group 4: Safety and Tolerability - HTD1801 exhibited good safety and tolerability over the long term, with no increase in the type or severity of adverse events compared to the double-blind phase results [5]
君圣泰医药-B(02511.HK)：全球首创抗炎代谢调节剂HTD1801完成2型糖尿病III期临床研究展现持续52周的综合获益与安全性优势