Rivus Pharmaceuticals has successfully concluded the enrollment phase for the Phase 2a HuMAIN Trial of HU6

Saturday, January 06, 2024

Rivus Pharmaceuticals Inc., a clinical-stage biopharmaceutical company dedicated to enhancing cardiometabolic health, has successfully concluded the enrollment phase for its Phase 2a HuMAIN trial of HU6. HU6 is an investigative controlled metabolic accelerator (CMA) developed for patients with the obese phenotype of heart failure with preserved ejection fraction (HFpEF). Company executives are set to provide an update during a presentation at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco on January 8.

Dr. Jayson Dallas, the CEO of Rivus Pharmaceuticals, emphasized the substantial progress made in advancing the HU6 clinical development program. He underscored the urgent need for a disease-modifying treatment for the at-risk population suffering from HFpEF, characterized by older age, obesity, and limited mobility, along with multiple metabolic comorbidities. Dr. Dallas explained that by increasing metabolism and reducing adiposity, a key underlying cause of HFpEF, HU6 has the potential to modify disease progression. The company plans to release topline data in mid-2024 and initiate a Phase 3 trial in 2025.

Rivus Pharmaceuticals is actively enrolling subjects with obesity and Type 2 diabetes into the ongoing Phase 2b M-ACCEL trial of HU6, which aims to address metabolic dysfunction-associated steatohepatitis (MASH). Topline data from the M-ACCEL trial is expected in early 2025.

The Phase 2a HuMAIN trial, a randomized, double-blind, placebo-controlled study, evaluated ascending doses of HU6 in patients with the obese phenotype of HFpEF. Sixty-five participants were randomized and dosed 1:1 with HU6 or placebo, with the primary outcome measure being weight reduction. The Phase 2b M-ACCEL trial, a randomized, double-blind, placebo-controlled study, is assessing the safety and efficacy of HU6 in patients with obesity and Type 2 diabetes at risk of MASH.

Rivus Pharmaceuticals will present at the 42nd Annual J.P. Morgan Healthcare Conference on January 8, providing further details on their developments in the private company track.

Rivus Pharmaceuticals is at the forefront of developing controlled metabolic accelerators (CMAs), a new class of investigational medicines aimed at improving metabolic health in individuals with obesity and associated metabolic diseases. HU6, the most advanced CMA in clinical development, leverages mitochondrial uncoupling to increase resting metabolic rate, leading to fat-selective weight loss and improved metabolic parameters. The company is exploring clinical development programs for HU6 in various conditions, including heart failure with preserved ejection fraction (HFpEF), metabolic dysfunction-associated steatohepatitis (MASH), Type 2 diabetes, and chronic weight management/obesity.

Source: prnewswire.com