HIGHTIDE-B (02511) announced that it showcased renal benefits data for HTD1801 in patients with mild renal impairment at the 58th American Society of Nephrology (ASN) Annual Meeting in Houston, USA. Clinical results demonstrated that HTD1801 has the potential to improve eGFR changes and restore renal function in early-stage chronic kidney disease (CKD) patients, offering substantial health benefits.
HTD1801 is a first-in-class anti-inflammatory metabolic modulator (AIMM) designed to address cardiorenal metabolic (CKM) disorders through dual mechanisms of AMPK activation and NLRP3 inhibition. The presented data were derived from a pooled analysis of two randomized, double-blind, placebo-controlled Phase III clinical trials (SYMPHONY 1 & 2; N=956) in type 2 diabetes (T2DM) patients.
Post-hoc subgroup analyses were conducted on patients with mild renal impairment (baseline eGFR: 60-90 ml/min/1.73m²) and hyperfiltration (baseline eGFR≥120 ml/min/1.73m²), using eGFR changes as the primary endpoint to assess HTD1801's renal effects. Results showed that in mild renal impairment patients, HTD1801 significantly improved eGFR versus placebo, with positive eGFR slopes during treatment. In hyperfiltration patients, HTD1801 reduced eGFR compared to placebo, suggesting potential normalization of renal function.
Additionally, HTD1801 showed no adverse effects on blood pressure, serum sodium, or potassium levels.