Versanis Announces Initiation of the BELIEVE Global Phase 2b Study of Bimagrumab as a Novel Treatment for Obesity

Bimagrumab is a first-in-class monoclonal antibody targeting activin type II receptors to drive substantial fat loss coupled with muscle gain   

BELIEVE will assess the safety and efficacy of bimagrumab alone and in combination with semaglutide in non-diabetic patients with overweight or obesity

NEW YORK, Jan. 12, 2023 /PRNewswire/ -- Versanis Bio ("Versanis"), a clinical-stage biopharmaceutical company advancing novel therapeutics for cardiometabolic diseases, today 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 U.S., Australia, and New Zealand.

Bimagrumab is a first-in-class, fully human monoclonal antibody targeting activin type II receptors. 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, 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.

"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."

BELIEVE is a randomized, placebo-controlled, 48-week global Phase 2b study targeting enrollment 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. More information about BELIEVE is available on clinicaltrials.gov (NCT05616013).

BELIEVE is a Phase 2b study in non-diabetic patients with overweight or obesity investigating the safety and efficacy of bimagrumab alone and in combination with semaglutide. 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.

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. Since initial development, bimagrumab has been administered to more than 1,000 patients for up to 18 months across more than 20 clinical studies. It is now being advanced as a novel treatment for patients living with obesity, with additional indications to follow.

Versanis is a privately held, clinical-stage biopharmaceutical company bringing transformational treatments to people living with cardiometabolic disease. The company's lead asset, bimagrumab, is being advanced in a Phase 2b study as a novel treatment for obesity to help adults achieve and maintain both substantial fat loss and a healthy body composition, with additional indications to follow. Versanis was founded in 2021 and is a portfolio company of Aditum Bio, Atlas Venture, and Medicxi. For more information, please visit www.versanisbio.com.

SOURCE Versanis Bio