The first clinical evidence that a therapy may benefit patients with chronic kidney disease (CKD) by improving the eGFR trajectory and recovering kidney function at the earliest stages of CKD
ROCKVILLE, MD and SHENZHEN, CHINA – [Nov 6, 2025] – HighTide Therapeutics, Inc. (2511.HK), a biopharmaceutical company specializing in the development of multifunctional, multi-targeted therapies for chronic metabolic diseases, today presented the evidence of kidney benefit with HTD1801 in patients with mild renal impairment at the 58th Annual Meeting of the American Society of Nephrology (ASN) in Houston, US.
HTD1801 is a first-in-class anti-inflammatory metabolic modulator (AIMM) with a dual mechanism of AMPK activation and NLRP3 inhibition to address the residual risks associated with cardiovascular-kidney-metabolic (CKM) diseases.
Data from two randomized, double-blind, placebo-controlled Phase III studies of HTD1801 in patients with type 2 diabetes mellitus (T2DM) (SYMPHONY 1 & 2; N=956) were pooled for analysis. Post-hoc subgroup analyses of the pooled data evaluated the effect of HTD1801 on renal function using eGFR trajectory. Mild renal impairment was defined as baseline eGFR 60-90 ml/min/1.73m2, and hyperfiltration was defined as baseline eGFR ≥120 ml/min/1.73m2.
In patients with mild renal impairment, treatment with HTD1801 was associated with a meaningful improvement in eGFR compared with placebo, resulting in a positive eGFR slope over time. In patients with hyperfiltration, HTD1801 led to a reduction in eGFR relative to placebo, consistent with a normalization of renal function. HTD1801 treatment demonstrated no clinically relevant effects on blood pressure, serum sodium or potassium.
Abstract Title: Evidence of Kidney Benefit with HTD1801 in Patients with Mild Renal Impairment
Presentation Number: TH-PO1190
Presentation Date/Time: 10:00 AM-12:00 PM November 6, 2025
Format: Poster Presentation
Presenting Author: Filip Surmont, MD; Leili Gao, MD; Kui Liu, MD; Leigh MacConell, PhD, Meng Yu, MSc; Liping Liu, PhD; Linong Ji, MD, on behalf of the SYMPHONY Investigators
“These results reinforce HTD1801’s potential to meaningfully impact kidney health,” said Dr. Liping Liu, Founder, Chairperson, and CEO of HighTide Therapeutics. “The improvements in eGFR among patients with mild renal impairment, coupled with normalization of hyperfiltration, suggest that HTD1801 may help restore kidney function balance. Building on these encouraging findings, we look forward to further evaluating the safety and efficacy of HTD1801 in a Phase II renal study in patients with chronic kidney disease.”
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 a unique dual mechanism of action through activation of AMP Kinase and inhibition of the NLRP3 inflammasome, 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 a biopharmaceutical company dedicated to developing multifunctional, multi‐targeted therapies for chronic metabolic diseases, with a strategic emphasis to address the residual risks of cardiovascular-kidney-metabolic (CKM) syndrome. 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 chronic metabolic 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