HighTide Therapeutics, Inc. (2511.HK), a biopharmaceutical company specialising 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 Centre for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) later this year.

SYMPHONY-1 (NCT06350890) and SYMPHONY-2 (NCT06353347) are randomised, 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 haemoglobin (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.