Rivus Pharmaceuticals has unveiled the data behind its phase 2 obesity win in heart failure patients, showing that the candidate can indeed help patients reduce weight while they retain muscle.
The asset, dubbed HU6, is designed to boost the breakdown of fat by stopping it from accumulating, rather than by reducing calory intake. The mechanism could help patients lose fat tissue while preserving muscle—the goal of many next-gen obesity drugs.
Sparing muscle is particularly important for heart failure patients, who may already be frail and lack skeletal muscle mass. The HuMAIN study specifically recruited patients with obesity-related heart failure with preserved ejection fraction.
Rivus already announced in August that the trial hit its key endpoint, but today fleshed out that win with some figures. Specifically, patients who ended on the highest, 450 mg, daily dose of HU6 lost an average of 6.8 pounds after three months, which was 6.3 pounds more than lost among the placebo group.
When it came to visceral fat—a term for fat that collects around the internal organs in the abdomen—this was reduced by 1.5% from baseline. What’s more, there was “no significant reduction in lean body mass with HU6 from baseline or compared with placebo,” said the company, keeping alive hopes that the drug can indeed help patients lose the right type of weight.
Elsewhere, HU6 was tied to reductions in systolic and diastolic blood pressure from baseline of 8.8 mmHg and 4.1 mmHg, respectively. These reductions weren’t linked to an increase in heart rate, the biotech noted.
The 66 patients enrolled in the study were mainly elderly and obese, with multiple comorbidities and taking an average of 15 other medicines. The most common treatment-emergent adverse events were diarrhea, COVID-19 and shortness of breath, with most of these events being mild to moderate in severity. There were no treatment-related serious adverse events.
HU6 is known as a controlled metabolic accelerator (CMA), a new class of therapies that Rivus hopes can “promote sustained body fat loss while preserving muscle mass.”
“With these new clinical data, which highly correlate to the results from our phase 2 study in [metabolic dysfunction-associated steatotic liver disease], we have now observed in different populations that HU6, a novel CMA, reduced fat mass and preserved lean body mass, which is especially beneficial in patients with HFpEF,” Rivus CEO Jayson Dallas, M.D., said in a statement.
“The positive HuMAIN results support the potential differentiating profile of HU6 in HFpEF, which could be the first disease-modifying treatment for this debilitating syndrome,” Dallas added. “The findings also support advancing our HFpEF clinical program with HU6.”
Roche is one high-profile entrant in the obesity space that has its own solution to retaining muscle. The Swiss pharma hopes that combining an injectable dual GLP-1/GIP receptor agonist acquired with Carmot alongside its own anti-myostatin antibody could also help patients reduce the muscle loss typically associated with losing weight.