Rivus Pharmaceuticals today announced publication of the rationale and design of the company’s Phase 2a HuMAIN trial in the European Journal of Heart Failure.
| – Study evaluating HU6 in patients with obesity-related heart failure with preserved ejection fraction is on track to report topline data in the second half of 2024 – – HU6, a novel Controlled Metabolic Accelerator, is a new class of investigational medicines designed to reduce weight while preserving muscle – CHARLOTTESVILLE, Va. and SAN FRANCISCO, June 26, 2024 /PRNewswire/ -- Rivus Pharmaceuticals Inc., a clinical-stage biopharmaceutical company dedicated to improving metabolic health, today announced publication of the rationale and design of the company’s Phase 2a HuMAIN trial in the European Journal of Heart Failure. Rivus has completed patient enrollment in this clinical trial of HU6, an investigational Controlled Metabolic Accelerator (CMA), in patients with obesity-related heart failure with preserved ejection fraction (HFpEF) and expects to report topline data in the second half of 2024.
“HuMAIN is the first clinical trial to evaluate the effects of a CMA in patients with obesity-related HFpEF, who have a median survival rate of around two years following hospitalization,” said Jayson Dallas, M.D., chief executive officer, Rivus Pharmaceuticals. “HU6 has the potential to be the first disease-modifying treatment for HFpEF. We look forward to further evaluating the potential benefits of HU6 in this large and growing patient population and sharing topline results in the second half of 2024.” HFpEF is a chronic debilitating syndrome characterized by severely reduced exercise capacity, which degrades quality of life. Obesity is a major independent risk factor for HFpEF and key contributor to the increasing worldwide prevalence of this disorder, with as many as 80% of patients with HFpEF in Western countries either overweight or obese. Weight loss approaches that involve dieting, bariatric surgery and GLP-1 agonists work by decreasing energy intake rather than by increasing energy expenditure. In addition to loss of fat, these approaches result in marked reductions in muscle mass, which can lead to impaired function in patients with HFpEF, who are typically elderly and frail and already have reduced muscle mass. “Given the limitations of current options for patients with obesity-related HFpEF, novel disease-modifying treatments are urgently needed,” said Dalane W. Kitzman, M.D., lead author of the publication and professor of internal medicine and cardiovascular medicine at Wake Forest University School of Medicine. “As detailed in this new publication, HU6 reduces fat, which is pivotal to the development of HFpEF, by increasing energy expenditure while preserving muscle. The Phase 2a trial will examine HU6’s potential to improve key outcomes in HFpEF, including increasing exercise capacity and quality of life, reducing systemic inflammation, and improving blood pressure and glucose metabolism.” About the Phase 2a HuMAIN Trial The primary efficacy endpoint is weight reduction (as measured by the change from baseline in body weight at Day 134). The key secondary efficacy endpoint is exercise capacity (as measured by the change from baseline in peak VO2 [mL/kg/min] during a standardized, noninvasive cardiopulmonary exercise test at Day 134). The effects of HU6 on disease-specific quality of life, changes in body composition and cardiac function/structure, and markers of cardiometabolic dysfunction (e.g., changes in blood pressure and pulse, glucose control, inflammation, lipid levels and liver fat and liver enzymes) are also being evaluated. The study is designed to identify the optimal dose of HU6 for Phase 3 trials. HuMAIN is being conducted at 22 clinical sites in the United States. About Controlled Metabolic Accelerators (CMAs) About HU6 The current clinical development of HU6 is focused on metabolic diseases with the most morbidity and greatest treatment needs: heart failure with preserved ejection fraction (HFpEF) and metabolic dysfunction-associated steatohepatitis (MASH)/MASLD. About Rivus Pharmaceuticals Contact: References
SOURCE Rivus Pharmaceuticals |
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