Junshengtai Pharmaceutical-B (02511) announced that two phase 3 clinical trials of HTD1801 in patients with type 2 diabetes have reached the main end

Zhitong Finance App News, Junshengtai Pharmaceutical-B (02511) announced that two phase 3 clinical trials (SYMPHONY 1 and SYMPHONY 2) conducted on Chinese type 2 diabetes (T2DM) patients with type 2 diabetes (T2DM), an enterohepatic anti-inflammatory and metabolic regulator independently developed by the company, reached the main curative end point and several secondary efficacy endpoints. HTD1801

The results of these two phase 3 clinical trials fully proved that HTD1801 is multi-effective and provides comprehensive benefits to T2DM patients. Based on the positive clinical trial data released this time, Junshengtai Pharmaceutical plans to submit a new drug marketing application (NDA) for HTD1801 to treat T2DM indications to the China Drug Administration (NMPA) Drug Evaluation Center (CDE) within this year.

According to reports, the SYMPHONY 1 (NCT06350890) and SYMPHONY 2 (NCT06353347) trials are two multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trials to separately evaluate the efficacy and safety of HTD1801 in T2DM patients with poor blood sugar control (SYMPHONY 1; N=407) and metformin control (SYMPHONY 2; N=549) after diet and exercise intervention. The main efficacy endpoints in both studies were changes in glycated hemoglobin (HbA1c) compared to placebo after 24 weeks of HTD1801 treatment. Secondary endpoints included percentage of subjects reaching HbA1c < 7.0%, fasting blood sugar (FPG), low density lipoprotein cholesterol (LDL-C), gamma-glutamyltransferase (GGT), and hypersensitive C-reactive protein (hs-CRP).

In both phase 3 clinical studies, it was observed that HbA1c in the HTD1801 treatment group showed a continuous decline over time during the treatment period, suggesting that HTD1801 has the potential to improve blood sugar metabolism in T2DM patients for a long time.

In both studies, the proportion of patients who achieved HbA1c < 7.0% in the HTD1801 treatment group was significantly higher than in the placebo group after 24 weeks of treatment. Compared with placebo, HTD1801 can significantly reduce both postprandial blood sugar and fasting blood sugar. Furthermore, HTD1801 shows the ability to lower glycolipids and can significantly reduce low-density lipoprotein cholesterol (LDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C). Additionally, HTD1801 treatment can reduce the inflammatory markers gamma-glutamyltransferase (GGT) and hypersensitive C-reactive protein (hs-CRP), which are closely related to cardiovascular events and clinical outcomes in T2DM patients.

In both studies, HTD1801 showed good safety and tolerability. The most common adverse event was gastrointestinal adverse reaction, which is consistent with the results of previous clinical studies. Fewer than 2% of subjects were likely to discontinue medication due to adverse events. There was no significant risk of hypoglycemia.