Core Viewpoint - Junsheng Tai Pharmaceutical-B (02511) has announced that its self-developed intestinal and hepatic anti-inflammatory and metabolic regulator, HTD1801, has achieved primary efficacy endpoints and multiple secondary efficacy endpoints in two Phase 3 clinical trials for Type 2 Diabetes Mellitus (T2DM) patients [1][2]. Group 1: Clinical Trial Results - The SYMPHONY 1 and SYMPHONY 2 trials are multi-center, randomized, double-blind, placebo-controlled Phase 3 studies aimed at evaluating the efficacy and safety of HTD1801 in T2DM patients with poor blood glucose control after dietary and exercise interventions (SYMPHONY 1; N=407) and those with inadequate control on metformin (SYMPHONY 2; N=549) [2]. - The primary efficacy endpoint for both studies was the change in glycated hemoglobin (HbA1c) from baseline after 24 weeks of treatment compared to placebo, with secondary endpoints including the percentage of subjects achieving HbA1c <7.0%, fasting plasma glucose (FPG), low-density lipoprotein cholesterol (LDL-C), gamma-glutamyl transferase (GGT), and high-sensitivity C-reactive protein (hs-CRP) [2]. Group 2: Efficacy and Safety Profile - After 24 weeks of treatment, the proportion of patients achieving HbA1c <7.0% in the HTD1801 group was significantly higher than in the placebo group, with HTD1801 also showing significant reductions in both postprandial and fasting blood glucose levels [3]. - HTD1801 demonstrated the ability to lower both glucose and lipids, significantly reducing LDL-C and non-HDL-C levels, as well as inflammatory markers GGT and hs-CRP, which are closely related to cardiovascular events and clinical outcomes in T2DM patients [3]. - Both studies indicated that HTD1801 exhibited good safety and tolerability, with the most common adverse events being gastrointestinal in nature, consistent with previous clinical findings, and less than 2% of subjects discontinued due to adverse events, with no significant risk of hypoglycemia observed [3].
君圣泰医药-B(02511)宣布熊去氧胆小檗硷(HTD1801)在2型糖尿病患者中开展的两项3期临床试验达到主要终点