Rivus Pharmaceuticals Reports Success in Reducing Liver Fat with Phase 2 HU6 Trial for MASH Patients

Rivus Pharmaceuticals Reports Positive Results

Rivus Pharmaceuticals, Inc., a pioneering biopharmaceutical company focused on combating obesity and associated cardiometabolic conditions, recently announced promising results from its Phase 2 M-ACCEL trial concerning the experimental drug HU6. This study evaluated the effectiveness of HU6 on patients suffering from metabolic dysfunction-associated steatohepatitis (MASH), a progressive liver condition linked closely to obesity.

Overview of the M-ACCEL Study

Conducted across 22 sites in the United States, the M-ACCEL trial was a randomized, double-blind, placebo-controlled study involving 221 adult participants. The primary goal was to gauge the percentage change in liver fat content after 6 months of treatment as assessed through advanced magnetic resonance imaging techniques. The results were remarkable, meeting the primary endpoint with statistically significant reductions in liver fat across the different treatment groups receiving various doses of HU6.

Key Findings

The trial found that patients administered HU6 exhibited significant decreases in liver fat content at six months when compared to a placebo group, showcasing a p-value of less than 0.01, which denotes strong statistical significance. Moreover, the study highlighted that a significant number of participants—over 30%—achieved a noteworthy reduction in liver fat, further emphasizing HU6's efficacy in potentially reversing aspects of MASH.

In addition to impacting liver fat, secondary endpoints demonstrated HU6's effectiveness in promoting weight loss and reducing both visceral fat and body fat, alongside improvements in metabolic markers such as blood pressure and hemoglobin A1c levels. Crucially, this was achieved without compromising lean muscle mass, which is a common issue with existing interventions.

Clinical Importance of MASH

MASH is a serious health concern affecting a growing demographic in the United States, with studies estimating around 5% of U.S. adults afflicted. The disease is particularly alarming as it can progress to liver cirrhosis, liver failure, and hepatocellular carcinoma, establishing it as a leading cause of liver transplantation. Coupled with rising obesity rates, MASH's prevalence poses a significant challenge to public health.

As Dr. Mazen Noureddin, a prominent figure in liver diseases, commented,