HighTide Therapeutics Announces Oral Presentation of Phase 3 Data in Patients with Type 2 Diabetes

▴ HighTide Therapeutics
HighTide Therapeutics, Inc. (2511.HK) is an innovative biopharmaceutical company specializing in metabolic diseases.
HONG KONG, Sep 17, 2025 - (ACN Newswire) – HighTide Therapeutics, Inc. (2511.HK), a clinical stage biopharmaceutical company specializing in the development of multifunctional multi-targeted therapies for metabolic diseases, announced that data from the Phase 3 SYMPHONY 2 trial evaluating the safety and efficacy of HTD1801 in patients with type 2 diabetes mellitus (T2DM) is being presented at the 61st Annual Meeting of the European Association for the Study of Diabetes (EASD) in Vienna. HTD1801, is a first-in-class anti-inflammatory metabolic modulator that activates AMPK and inhibits the NLRP3 inflammasome. These pathways converge at the nexus of metabolic dysregulation beyond glucose control and chronic inflammation. This randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of HTD1801 compared to placebo in patients with T2DM inadequately controlled with metformin. The primary endpoint of Symphony 2 was change from baseline in HbA1c to Week 24 compared to placebo. Secondary endpoints explored effects on cardiovascular, metabolic, and renal comorbidities to assess it’s potential as a comprehensive Cardiovascular-Kidney-Metabolic therapy. Eligible patients were randomized 2:1 to HTD1801 1000 mg BID (N=365) or placebo (N=184). The study met the primary endpoint at Week 24, with HTD1801-treated patients achieving an LS mean change in HbA1c of -1.21% compared to -0.68% with placebo (LS mean diff: -0.53, p
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