ROCKVILLE, MD and SHENZHEN, CHINA, September 2, 2026 – HighTide Therapeutics, Inc. (2511.HK), an innovative biopharmaceutical company specializing in the development of multifunctional, multi-targeted therapies for cardiovascular–kidney–metabolic (CKM) diseases, announced that Diabetes Care, a leading international medical journal, has published two articles featuring HTD1801: the primary results from the Phase 3 SYMPHONY-1 study evaluating HTD1801 monotherapy in adults with type 2 diabetes mellitus (T2DM), led by Director of the Department of Endocrinology at Peking University People’s Hospital; and a review article on recent advances in diabetes therapies in Asia, with Professor Ji as the corresponding author. The review was also first presented by Professor Ji at the International Diabetes Federation Western Pacific Region Congress (IDF-WPR 2026) on August 21.
SYMPHONY-1 was a randomized, double-blind, placebo-controlled Phase 3 clinical study designed to evaluate the efficacy and safety of HTD1801 in adults with T2DM inadequately controlled with diet and exercise. Results published in Diabetes Care demonstrated that:
- Sustainable glycemic control: At Week 24, HTD1801 group achieved a change in HbA1c of –1.3% versus –0.6% with placebo. HbA1c reductions were durable through 52 weeks.
- Comprehensive benefits: After 24 weeks of HTD1801 treatment, significant improvements were observed in key cardiometabolic and inflammatory markers.
- Favorable safety profile: The most common adverse events were mild to moderate diarrhea, most of which occurred at treatment initiation. Longer-term safety (56 weeks) was consistent with safety findings of the double-blind trial.
The review article highlights HTD1801 as an innovative therapy that exerts its biological activity through the AMPK–NLRP3 axis. It positions HTD1801 as an emerging therapeutic approach that represents a new direction in diabetes treatment, extending beyond glycemic control toward broader cardiometabolic and inflammatory benefits.
Professor Linong Ji, Director of the Department of Endocrinology at Peking University People’s Hospital, said: “HTD1801, with its unique dual mechanism around AMPK and NLRP3, has demonstrated sustained glycemic control and comprehensive cardiometabolic and inflammatory benefits in clinical studies. Its potential to address multiple metabolic abnormalities through a differentiated mechanism reflects the evolution of innovative therapies toward more comprehensive disease management.”
Filip Surmont, M.D., Chief Medical Officer of HighTide Therapeutics, said: “The publication of the SYMPHONY-1 results in Diabetes Care further strengthens the clinical evidence supporting HTD1801 in T2DM. The study demonstrated sustained improvements in glycemic control, along with favorable effects on key cardiometabolic and inflammatory markers. Professor Linong Ji’s review further highlights the differentiated mechanism and therapeutic potential of HTD1801 in T2DM and CKM diseases. We look forward to further exploring the comprehensive therapeutic potential of HTD1801 in CKM diseases and providing new treatment options for patients.”
Diabetes Care is a peer-reviewed academic journal published by the American Diabetes Association (ADA), with a 2025 Journal Impact Factor of 22.6.
About HTD1801
HTD1801 is a first-in-class new molecular entity that targets the residual risks underlying cardiovascular–kidney–metabolic (CKM) diseases. It is an orally delivered, anti-inflammatory metabolic modulator (AIMM) that, as a single molecule, exerts its biological activity through the AMPK–NLRP3 axis, two complementary pathways that mitigate metabolic dysfunction. Multiple global clinical studies have demonstrated the comprehensive benefits of HTD1801, including improved insulin sensitivity, glycemic control, lipid lowering, renal protection, weight reduction, hepatic improvement, and anti-inflammatory effects. Collectively, these findings support the potential of HTD1801 to serve as a foundational therapy in CKM disease management.
About HighTide Therapeutics
HighTide Therapeutics, Inc. (2511.HK) is an innovative biopharmaceutical company dedicated to developing multifunctional, multi-targeted therapies for cardiovascular-kidney-metabolic (CKM) diseases. The company focuses on delivering breakthrough treatments that generate comprehensive, multi-organ benefits for patients worldwide. HighTide has built an innovative, globally integrated pipeline of proprietary assets and advanced multiple clinical programs across CKM diseases. The company’s lead asset, HTD1801, has received two Fast Track designations and one Orphan Drug designation from the US Food and Drug Administration (FDA), and has been selected for China’s National Major Science and Technology Project for Significant New Drug Development.
For more information, please visit www.hightidetx.com. Contact: pr@hightidetx.com