Japan – HTD1801, a First-in-Class Anti-inflammatory Metabolic Modulator, Demonstrates Durable 52-Week Efficacy and Safety in Two Phase III Trials in Type 2 Diabetes Mellitus

HTD1801, a First-in-Class Anti-inflammatory Metabolic Modulator, Demonstrates Durable 52-Week Efficacy and Safety in Two Phase III Trials in Type 2 Diabetes Mellitus

– These 52-week information enhance HTD1801’s capacity as a really separated healing to simultaneously resolve metabolic dysregulation, swelling, and kidney development in type 2 diabetes mellitus

HONG KONG, Oct 31, 2025 – (ACN Newswire)–HighTide Therapeutics, Inc. (2511. HK), a biopharmaceutical business concentrating on the advancement of multifunctional, multi-targeted treatments for persistent metabolic illness, revealed favorable 52-week security and effectiveness arise from the open-label extension (OLE) stages of 2 Phase III trials (SYMPHONY-1 and SYMPHONY-2) assessing HTD1801 in clients with type 2 diabetes mellitus (T2DM).

The 52-week information from these 2 Phase III medical trials show the sturdiness of reaction and highlight the detailed long-lasting scientific advantages of HTD1801 in clients with T2DM. HighTide prepares to send a brand-new drug application (NDA) for HTD1801 as a treatment for T2DM to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) later on this year.

SYMPHONY-1 (NCT06350890) and SYMPHONY-2 (NCT06353347) are randomized, double-blind, placebo-controlled, Phase III medical trials created to examine the effectiveness and security of HTD1801 in grownups with T2DM and insufficient glycemic control in spite of diet plan and workout (SYMPHONY-1; N=408) or with Metformin (SYMPHONY-2; N=551). The main endpoint in both research studies was the modification in glycated hemoglobin (HbA1c) from standard with HTD1801 compared to placebo after 24 weeks of treatment. Clients were qualified to continue in a 28-week OLE throughout which all clients got HTD1801; Durability of reaction throughout effectiveness endpoints was examined based upon the modification from standard to Week 52.

Effectiveness observed throughout the 24-week double-blind duration was resilient and preserved with longer-term treatment through 52 weeks in both research studies

SYMPHONY-1 (HTD1801 as monotherapy): At week 24, the decrease from standard in HbA1c with HTD1801 (-1.3%) transcended to placebo. HbA1c decreases were preserved in clients who continued getting HTD1801 (-1.2% at Week 52). Placebo clients who changed to HTD1801 saw a decrease in HbA1c of -1.3% at Week 52, corroborating the double-blind stage findings.

SYMPHONY-2 (HTD1801 as an add-on treatment to Metformin): At week 24, the decrease from standard in HbA1c with HTD1801 (-1.2%) transcended to placebo. HbA1c decreases were sustained in clients who continued getting HTD1801 (-1.1% at Week 52). Placebo clients who changed to HTD1801 saw a decrease in HbA1c of -1.2% at Week 52, likewise corroborating the double-blind stage findings.

In both research studies, the resilience of impact on other cardiometabolic and kidney endpoints was preserved at 52 weeks, recommending thorough benefits of HTD1801 beyond glycemic control with long-lasting treatment.

In both research studies, the percentage of clients getting HTD1801 throughout the double-blind stage who attained target HbA1c<