Rivus supports muscle-sparing claims of obesity drug with phase 2 data

Rivus Pharmaceuticals recently disclosed data from its phase 2 clinical trial, which showcased the efficacy of its experimental drug HU6 in managing obesity among heart failure patients. HU6, classified as a controlled metabolic accelerator (CMA), represents a novel therapeutic approach aimed at fostering sustained fat loss while maintaining muscle mass.

The trial, known as the HuMAIN study, focused on patients with heart failure with preserved ejection fraction (HFpEF) intertwined with obesity. This particular subset of patients is often frail, with diminished skeletal muscle mass, making the preservation of muscle tissue during weight loss especially critical. Rivus previously announced that the trial met its primary endpoint in August, but the recent data release provided further insights into the drug’s performance.

Participants who received the highest daily dose of HU6, which was 450 mg, experienced an average weight reduction of 6.8 pounds over a three-month period. This weight loss was notably higher by 6.3 pounds compared to the placebo group. Additionally, HU6 demonstrated efficacy in reducing visceral fat—fat that envelops internal organs in the abdomen—by 1.5% from the baseline.

Importantly, the study indicated that there was no significant decrease in lean body mass either from baseline or when compared with the placebo group. This finding aligns with the drug’s goal of promoting fat loss while preserving muscle tissue, a critical consideration for this patient cohort.

The trial also noted beneficial effects on blood pressure, with reductions in both systolic and diastolic measures from the baseline by 8.8 mmHg and 4.1 mmHg, respectively. These improvements were achieved without an associated increase in heart rate.

The 66 patients enrolled in the HuMAIN study were predominantly elderly, obese, and managing multiple health conditions, taking an average of 15 different medications. The most frequently reported adverse events included diarrhea, COVID-19, and shortness of breath, with most incidents ranging from mild to moderate. Notably, no serious adverse events directly related to the treatment were observed.

Dr. Jayson Dallas, CEO of Rivus Pharmaceuticals, expressed optimism about the new clinical data. He highlighted that the results were consistent with findings from a previous phase 2 study in patients with metabolic dysfunction-associated steatotic liver disease. According to Dallas, HU6’s ability to reduce fat mass while preserving lean body mass is particularly advantageous for patients with HFpEF.

Dallas further emphasized the potential of HU6 to become a pioneering disease-modifying treatment for HFpEF, a condition that currently lacks effective therapeutic options. The latest findings are expected to bolster Rivus’ clinical program aimed at advancing HU6 for HFpEF patients.

In the broader landscape of obesity treatment, Roche is also making strides by developing a combination therapy that includes an injectable dual GLP-1/GIP receptor agonist acquired from Carmot alongside an anti-myostatin antibody. This approach aims to address muscle loss, a common challenge associated with weight reduction therapies.

Rivus Pharmaceuticals' development of HU6 and the promising results from the HuMAIN study signify a noteworthy advancement in the treatment of obesity-related heart failure, offering hope for a new, effective therapeutic option that balances fat loss with muscle preservation.