The trials are assessing the safety and efficacy of bimagrumab alone and in combination with semaglutide for the treatment of obesity.
The fully human monoclonal antibody is the only candidate in clinical development for the treatment of obesity that drives substantial fat loss while also increasing muscle mass (in contrast, approximately one third of the weight loss with semaglutide and other incretin therapies derives from reduced lean mass with associated loss of muscle).
"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 Kenneth Attie, M.D., 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."
Study to enroll 450 patients
The California company’s mission is to ‘transform the treatment landscape for obesity and cardiometabolic diseases’.
Bimagrumab is its lead candidate, which blocks activin type II receptors, directly targeting fat and muscle tissue.
So far, bimagrumab has been administered to more than 1,000 patients for up to 18 months across more than 20 clinical studies.
Most recently, the company reported 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.
Furthermore - unlike the rapid off-treatment rebound effect typically reported with incretin therapies - no weight regain was seen through 12 weeks after cessation of bimagrumab treatment).
The new Phase 2b BELIEVE study is a randomized, placebo-controlled, global Phase 2b study targeting enrollment of 450 non-diabetic patients with overweight or obesity.
Eligible patients with a body mass index ≥ 30, or ≥ 27 with one or more obesity-related comorbidities, will receive 48 weeks of treatment to assess safety and tolerability, along with improvement in key obesity measures, including changes in body weight, waist circumference, and body composition.
While bimagrumab is currently being advanced as a treatment for obesity patients, Versanis Bio says additional indications across broader cardiometabolic diseases will follow.