Rivus Pharmaceuticals has plumped up the prospects of its fat-busting, muscle-sparing drug candidate, reporting a primary endpoint hit in a phase 2a trial of people with obesity-related heart failure.
HU6 is designed to drive weight loss by boosting the breakdown of fat, stopping it from accumulating, rather than by reducing the intake of calories. The mechanism could help patients lose fat tissue while preserving muscle. Sparing muscle is particularly important for heart failure patients, who may already be frail and lack skeletal muscle mass.
Rivus put HU6 to the test by randomizing 66 people with obesity-related heart failure with preserved ejection fraction to take the candidate or placebo for 134 days. Subjects started on one oral dose, switched to a middle dose after 20 days and were finally moved to the top dose if the data supported escalation.
The study met its primary endpoint of change from baseline in body weight after 134 days. Rivus plans to share the data behind the primary endpoint hit at a scientific meeting in September. The biotech said the trial met several secondary efficacy and pharmacodynamic endpoints and showed HU6 has a favorable safety profile, again without sharing any data to support its statement.
Jayson Dallas, M.D., Rivus’ CEO, said in a statement that the data reinforce the possibility of HU6 being “used in a broad range of cardiometabolic diseases with significant morbidity and limited treatment options.” The focus could enable the biotech to carve out a niche in the competitive obesity space.
Rivus plans to move into phase 3 in heart failure. Talks with health authorities about the study are planned for next year. Rivus is preparing to advance HU6 in obesity-related heart failure while generating data in other settings. A phase 2 trial in metabolic dysfunction-associated steatohepatitis recently completed enrollment and is on track to deliver topline data in the first half of next year.