– Data from the proof-of-concept study showed berberine ursodeoxycholate was generally well tolerated and had beneficial therapeutic effect in improving glycemic, hepatic and cardiometabolic parameters
– The multifaceted effects demonstrated by berberine ursodeoxycholate support this new molecular entity as a unique oral treatment option for T2DM and its comorbidities
– T2DM phase 3 data readout is expected to be announced in the first half of 2025
HighTide Therapeutics, Inc. (HKG: 2511), a clinical stage biopharmaceutical company specializing in the development of multifunctional multi-targeted therapies for chronic liver and metabolic diseases, today announced that data from the Phase 2 proof-of-concept study evaluating berberine ursodeoxycholate (HTD1801) for the treatment of type 2 diabetes mellitus (T2DM) was published online in JAMA Network Open.
The publication reports results of the randomized, placebo-controlled 12-week study to assess efficacy, safety and tolerability of HTD1801 compared to placebo in patients with T2DM. The trial achieved its primary endpoint by demonstrating a statistically significant and superior reduction in HbA1c at week 12 with HTD1801 versus placebo. A majority of patients treated with HTD1801 achieved target HbA1c <7%. Further, results show therapeutic benefit of HTD1801 on LDL and total cholesterol, markers of liver injury and systemic inflammation. In this study, HTD1801 was well tolerated with no treatment-related serious adverse events observed. These findings are being confirmed in ongoing Phase 3 studies.
“We are encouraged by the results of this Phase 2 study. The study provides evidence that HTD1801 can treat the core aspects of metabolic syndrome, with potential to provide a spectrum of therapeutic effects that appear to address comorbid conditions that exacerbate disease and worsen prognosis of patients with T2DM,” said Dr. Linong Ji, Professor of Medicine at Peking University, Director of Peking University Diabetes Center and Director of the Department of Endocrinology and Metabolism, Peking University People’s Hospital, in Beijing, China.
“Based on these positive findings, we are continuing to advance the clinical development of HTD1801 in our ongoing Phase 3 T2DM program with topline results expected in the first half of this year,” said Dr. Liping Liu, CEO of HighTide Therapeutics.
About JAMA Network Open Journal
JAMA Network Open is an international, peer-reviewed, open access, general medical journal that publishes research on clinical care, innovation in health care, health policy, and global health across all health disciplines and countries for clinicians, investigators, and policy makers. JAMA Network Open is a member of the JAMA Network, a consortium of peer-reviewed, general medical and specialty publications.
About Berberine Ursodeoxycholate (HTD1801)
Berberine ursodeoxycholate (HTD1801) is an orally delivered, gut-liver anti-inflammatory metabolic modulator being developed for the treatment of metabolic and digestive diseases. HTD1801, an ionic salt of berberine and ursodeoxycholate, is a new molecular entity with unique dual mechanisms of action, including AMP kinase activation and NLRP3 inflammasome inhibition. These two key mechanistic pathways have been associated with improvements in glucose metabolism, insulin resistance, lipid metabolism, and hepatic inflammation, potentially providing a comprehensive treatment platform for the multifaceted nature of complex metabolic diseases such as T2DM.
About HighTide Therapeutics
HighTide Therapeutics, Inc. (HKG: 2511) is a globally integrated biopharmaceutical company focusing on the discovery and development of first-in-class multifunctional multi-targeted therapies with poly-indication potential across multiple metabolic and digestive diseases with significant unmet medical needs. The Company is currently developing several clinical assets and holding global intellectual property rights, advancing multiple mid-to-late-stage clinical trials including therapy for metabolic dysfunction-associated steatohepatitis (MASH), type 2 diabetes mellitus (T2DM), severe hypertriglyceridemia (SHTG) and primary sclerosing cholangitis (PSC). Berberine ursodeoxycholate (HTD1801), the Company’s lead drug candidate, received Fast Track designation from the United States Food and Drug Administration for both MASH and PSC and Orphan Drug designation for PSC. HTD1801 has been included in the National Major New Drug Innovation Program under the 13th Five-Year Plan for Major Technology Project in China.
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