GLASGOW and HONG KONG — HighTide Therapeutics, Inc. (2511.HK) today presented new findings on the renoprotective effects of its lead candidate HTD1801 in an oral presentation at the 63rd European Renal Association (ERA) Congress in Glasgow, UK. The data highlight the drug's potential as a disease-modifying therapy for chronic kidney disease (CKD) and other renal conditions.
HTD1801 is a first-in-class anti-inflammatory metabolic modulator (AIMM) targeting the AMPK-NLRP3 axis. In completed Phase III trials (SYMPHONY-1 and 2), HTD1801 demonstrated significant improvement in renal function in patients with Type 2 Diabetes Mellitus (T2DM) and baseline eGFR of 60–90 mL/min/1.73m². Treatment resulted in a mean increase of +3.08 mL/min/1.73m² in eGFR after 52 weeks (95% CI: 0.46–5.70), without evidence of hyperfiltration or fluid retention. These findings suggest HTD1801 may differentiate from existing therapies, with the potential to delay or prevent disease progression.
The study, conducted in collaboration with the research team led by Academician Jiandong Jiang at the Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences, explored the mechanistic basis behind these clinical observations. In glucose- and palmitic acid-induced podocyte injury models, HTD1801 significantly preserved podocyte viability and inhibited apoptosis. It also restored expression of key podocyte structural proteins nephrin and podocin, while reducing levels of the inflammatory marker phosphorylated NF-kB and the apoptosis executioner caspase-3. In a diabetic nephropathy (DN) model, HTD1801 demonstrated dose-dependent improvements in renal architecture, reduced tubular injury scores, attenuated renal inflammatory and fibrotic changes, and drove a robust decrease in 24-hour urinary microalbumin.
“This study provides the first evidence into the renoprotective effects of HTD1801 at the podocyte and glomerular levels. The convergence of clinical and preclinical data further supports the disease-modifying potential of HTD1801 and its ability to target fundamental pathophysiologic processes in CKD or other renal diseases,” said Dr. Filip Surmont, Chief Medical Officer of HighTide Therapeutics. “We will continue advancing the clinical development of HTD1801 across CKD and related indications to provide more treatment options for patients worldwide.”
HTD1801 is an orally delivered, anti-inflammatory metabolic modulator that, as a single molecule, exerts a unique dual mechanism of action through activation of AMP Kinase and inhibition of the NLRP3 inflammasome. Multiple global clinical studies have demonstrated comprehensive benefits, including improved insulin sensitivity, glycemic control, lipid lowering, renal protection, weight reduction, hepatic improvement, and anti-inflammatory effects. For more information, visit www.hightidetx.com.
