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 data reinforce HTD1801’s potential as a truly differentiated therapeutic to concurrently address metabolic dysregulation, inflammation, and renal progression in type 2 diabetes mellitus
HONG KONG, Oct 31, 2025 – (ACN Newswire) – HighTide Therapeutics, Inc. (2511.HK), a biopharmaceutical company specializing in the development of multifunctional, multi-targeted therapies for chronic metabolic diseases, announced positive 52-week safety and efficacy results from the open-label extension (OLE) phases of two Phase III trials (SYMPHONY-1 and SYMPHONY-2) evaluating HTD1801 in patients with type 2 diabetes mellitus (T2DM).
The 52-week data from these two Phase III clinical trials demonstrate the durability of response and highlight the comprehensive long-term clinical benefits of HTD1801 in patients with T2DM. HighTide plans to submit a 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 this year.
SYMPHONY-1 (NCT06350890) and SYMPHONY-2 (NCT06353347) are randomized, double-blind, placebo-controlled, Phase III clinical trials designed to evaluate the efficacy and safety of HTD1801 in adults with T2DM and inadequate glycemic control despite diet and exercise (SYMPHONY-1; N=408) or with Metformin (SYMPHONY-2; N=551). The primary endpoint in both studies was the change in glycated hemoglobin (HbA1c) from baseline with HTD1801 compared to placebo after 24 weeks of treatment. Patients were eligible to continue in a 28-week OLE during which all patients received HTD1801; Durability of response across efficacy endpoints was evaluated based on the change from baseline to Week 52.
Efficacy observed during the 24-week double-blind period was durable and maintained with longer-term treatment through 52 weeks in both studies
SYMPHONY-1 (HTD1801 as monotherapy): At week 24, the reduction from baseline in HbA1c with HTD1801 (-1.3%) was superior to placebo. HbA1c reductions were maintained in patients who continued receiving HTD1801 (-1.2% at Week 52). Placebo patients who switched to HTD1801 saw a reduction in HbA1c of -1.3% at Week 52, substantiating the double-blind phase findings.
SYMPHONY-2 (HTD1801 as an add-on therapy to Metformin): At week 24, the reduction from baseline in HbA1c with HTD1801 (-1.2%) was superior to placebo. HbA1c reductions were sustained in patients who continued receiving HTD1801 (-1.1% at Week 52). Placebo patients who switched to HTD1801 saw a reduction in HbA1c of -1.2% at Week 52, also substantiating the double-blind phase findings.
In both studies, the durability of effect on other cardiometabolic and renal endpoints was maintained at 52 weeks, suggesting comprehensive advantages of HTD1801 beyond glycemic control with long-term treatment.
In both studies, the proportion of patients receiving HTD1801 during the double-blind phase who achieved target HbA1c
