Versanis Bio, a clinical-stage biopharmaceutical company advancing novel therapeutics for cardiometabolic diseases, has announced that the BELIEVE Phase 2b study to assess the safety and efficacy of bimagrumab alone and in combination with semaglutide for the treatment of obesity has begun enrolling at sites in the US, Australia and New Zealand.
"Initiation of the BELIEVE study is a significant milestone in our journey to advance bimagrumab as a potentially transformational new treatment for obesity that can produce significant fat loss along with an increase in muscle mass, which provides better quality weight loss overall," said Dr Kenneth Attie, Chief Medical Officer at Versanis. "We are thrilled with the enthusiasm for the study and have already enrolled close to 20% of our targeted patients."
BELIEVE is a randomised, placebo-controlled, 48-week global Phase 2b study targeting enrolment of 450 non-diabetic patients with overweight or obesity who will receive placebo or bimagrumab, with or without semaglutide. The study will assess the safety and efficacy of bimagrumab both as a monotherapy and when co-administered with semaglutide. Support for the combination of bimagrumab and incretin therapy has been demonstrated in rodent models of obesity, where the co-administration of bimagrumab with semaglutide or tirzepatide was well tolerated and resulted in additive fat loss with complete reversal of the incretin-mediated muscle loss.
According to the company, Bimagrumab is a first-in-class, fully human IgG1/λ monoclonal antibody with picomolar affinity for both activin type II receptors A and B that blocks binding of ligands, including myostatin and activins. Bimagrumab decreases body fat, especially abdominal visceral fat, while at the same time increasing muscle mass.
The company claims it is the only candidate in clinical development for the treatment of obesity that drives substantial fat loss while also increasing muscle mass. In contrast, the company added, approximately one third of the weight loss with semaglutide and other incretin therapies derives from reduced lean mass with associated loss of muscle.
Extensive clinical safety and efficacy data for bimagrumab have been generated in more than 20 prior studies, with exposure in more than 1,000 patients for up to 18 months. This includes a 48-week Phase 2 study in patients with type 2 diabetes and overweight or obesity in whom bimagrumab produced a placebo-adjusted approximate 22% fat mass loss coupled with 4.5% lean mass gain, despite minimal change in caloric intake. Further, unlike the rapid off-treatment rebound effect typically reported with incretin therapies, no weight regain was observed through 12 weeks after cessation of bimagrumab treatment.