HighTide Therapeutics (2511) Announces HTD1801 Renal Benefit Findings at ASN 2025

Bulletin Express
11/07

HighTide Therapeutics, Inc. (2511) presented data at the 58th Annual Meeting of the American Society of Nephrology (ASN) in Houston, highlighting a potential renal benefit of HTD1801 in patients with mild renal impairment. HTD1801 is described as a first-in-class anti-inflammatory metabolic modulator (AIMM) with dual mechanisms—AMPK activation and NLRP3 inhibition—aimed at addressing risks associated with cardiovascular-kidney-metabolic (CKM) diseases.

The findings stem from two randomized, double-blind, placebo-controlled Phase III studies involving 956 participants with type 2 diabetes mellitus. Baseline eGFR data identified two subgroups: mild renal impairment (60–90 ml/min/1.73m²) and hyperfiltration (≥120 ml/min/1.73m²). Relative to placebo, HTD1801-treated patients in the mild renal impairment group showed an improvement in eGFR, while those with hyperfiltration experienced eGFR reduction that suggested normalization of renal function. No clinically relevant effects on blood pressure, serum sodium, or potassium were observed.

According to the announcement, HTD1801 has gained two Fast Track designations and one Orphan Drug designation from the US Food and Drug Administration. However, there is no assurance that HTD1801 will ultimately be successfully marketed. Shareholders and potential investors are advised to exercise caution when dealing in the shares of the company.

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