Rivus Pharmaceuticals Inc., a clinical-stage biopharmaceutical company dedicated to improving metabolic health, today announced its Phase 2a HuMAIN clinical trial of HU6 in patients with obesity-related heart failure with preserved ejection fraction (HFpEF) met its primary endpoint of weight reduction. HU6, an oral, once-daily potentially first-in-class investigational treatment, is a Controlled Metabolic Accelerator (CMA), which is designed to promote sustained body fat loss while preserving muscle mass. Treatment with HU6 resulted in a statistically significant weight reduction. Data from the HuMAIN study will be presented in a Late Breaking Clinical Trial Plenary Session at the Heart Failure Society of America (HFSA) Annual Scientific Meeting, taking place September 27-30, 2024, in Atlanta.
“Inflammation caused by visceral fat is an important driver of obesity-related HFpEF, and reductions in body fat have been shown to lead to improved outcomes in patients. The goal is to reduce body fat while preserving lean muscle mass, especially in this often fragile and elderly patient population,” said Jayson Dallas, M.D., chief executive officer, Rivus Pharmaceuticals. “We believe that the HuMAIN data strongly supports the potential of HU6 to be the first disease-modifying treatment for HFpEF by enabling fat-specific weight loss while preserving muscle, reinforcing the possibility for it to be used in a broad range of cardiometabolic diseases with significant morbidity and limited treatment options.”
In addition to meeting the primary endpoint, the HuMAIN study met several secondary efficacy and pharmacodynamic endpoints. The profile of HU6 was consistent with previous studies. HU6 was well tolerated, with a favorable safety profile, in a population of patients who had multiple co-morbidities and were on numerous concomitant medications. The rationale for the use of HU6 in HFpEF and the design of the HuMAIN study were recently published in the European Journal of Heart Failure.1 Rivus remains on track to engage health authorities for a Phase 3 study in obesity-related HFpEF in 2025.
Additionally, Rivus has completed patient enrollment in the Phase 2 M-ACCEL trial of HU6 in patients with metabolic dysfunction-associated steatohepatitis (MASH). Rivus remains on track to announce topline results from the M-ACCEL study in the first half of 2025.
To date, more than 400 patients have been treated as part of Rivus’ HU6 clinical development program.
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