Rivus Completes Enrollment in HU6 Phase 2a Trial

Rivus Pharmaceuticals, a biopharmaceutical firm focused on enhancing cardiometabolic health, has successfully completed participant recruitment for its Phase 2a HuMAIN clinical trial. The study is centered on HU6, a novel controlled metabolic accelerator (CMA), which is being tested on patients exhibiting the obese phenotype of heart failure with preserved ejection fraction (HFpEF). The company's leadership is scheduled to deliver a comprehensive corporate update at the 42nd Annual J.P. Morgan Healthcare Conference on January 8th, 2024.
Jayson Dallas, M.D., Rivus Pharmaceuticals' CEO, highlighted the importance of the HU6 clinical development program, emphasizing the urgency for a disease-modifying treatment for the vulnerable patient demographic, which is characterized by advanced age, obesity, limited mobility, and various metabolic co-morbidities. The HU6 treatment is anticipated to alter the disease's progression by boosting metabolism and substantially reducing adiposity, a primary cause of HFpEF. The company is targeting a mid-2024 announcement for the topline data and is planning to initiate a Phase 3 trial in 2025.
In addition to the HuMAIN trial, Rivus is also enrolling subjects in the Phase 2b M-ACCEL trial, which is focused on individuals with obesity and Type 2 diabetes who are at risk of metabolic dysfunction-associated steatohepatitis (MASH). The M-ACCEL trial's primary outcome measure is the percentage change in liver fat, as assessed by MRI-Liver PDFF, after six months of treatment. The study also aims to evaluate the effects of HU6 on body weight, glycemic control, liver fibrosis, body composition, metabolic and inflammatory parameters, and patient-reported outcomes. The M-ACCEL trial is expected to release its topline data in early 2025.
The Phase 2a HuMAIN trial is a randomized, double-blind, placebo-controlled study that assesses HU6's safety, tolerability, pharmacodynamics, and pharmacokinetics in escalating doses. The trial involves 65 participants with a BMI greater than 30 kg/m2, and the primary outcome measure is weight reduction. The study is being conducted across 14 clinical sites in the United States.
Controlled Metabolic Accelerators (CMAs), like HU6, are a new class of investigational medicines that aim to improve metabolic health for individuals with obesity and related metabolic diseases. These oral small molecules are designed to increase the resting metabolic rate, leading to enhanced energy consumption primarily from fat. The reduction in fat mass addresses several cardiometabolic conditions driven by adiposity. CMAs work by leveraging the natural metabolic process of mitochondrial uncoupling, which accounts for a significant portion of resting caloric consumption. This mechanism offers the advantage of fat-selective weight loss while preserving muscle mass, unlike caloric restriction strategies that result in the loss of both fat and muscle mass.
HU6, the leading CMA in clinical development, is specifically designed to increase the body's resting metabolic rate in a controlled and natural manner through mitochondrial uncoupling. In a Phase 2 metabolic trial involving patients with high BMI and metabolic dysfunction-associated steatotic liver disease (MASLD), HU6 demonstrated a reduction in liver fat content and body weight, preservation of lean muscle mass, and significant improvements in systemic inflammation and metabolism markers.
Rivus Pharmaceuticals, a pioneer in mitochondrial biology, is committed to advancing CMAs to treat obesity and associated metabolic diseases, including HFpEF, MASLD/MASH, and Type 2 diabetes. The company's lead CMA, HU6, is currently under development for these conditions.