Presentation at ENDO 2022 shows similar beneficial improvement in body composition irrespective of metabolic impairment
Phase 2b obesity study of bimagrumab monotherapy and co-administration with incretin therapy to start later this year
NEW YORK, June 11, 2022 /PRNewswire/ -- Versanis Bio ("Versanis"), a clinical-stage company advancing novel therapeutics for cardiometabolic diseases, will share analysis of Phase 2 data from prior studies of lead asset bimagrumab at ENDO 2022, being held virtually and in Atlanta June 11-14, 2022.
Dr. Lloyd Klickstein, Chief Scientific Officer of Versanis, will present the data during ENDO's Rapid Fire Poster session on Monday, June 13, from 12:30 until 1:30 p.m. EDT in Poster Pod 3, ENDOExpo Hall. The presentation is entitled "The Dramatic Fat Mass Loss Caused by Bimagrumab is Similar in Diabetic and Non-diabetic Patients." The results of the analysis underscore bimagrumab's robust activity in spurring fat loss in people with and without diabetes, while concomitantly increasing lean mass.
Bimagrumab is a first-in-class activin type II receptor monoclonal antibody previously evaluated in various muscle wasting indications based on its effects on muscle anabolism. This pooled analysis is based on five previously completed Phase 2 studies with data from a total of 569 non-diabetic patients, 41% of whom were overweight or obese.
After only 24 weeks of intravenous treatment with bimagrumab, the top dose group lost 14.6% of total body fat mass, while the placebo group showed a 2.4% increase in fat mass. This change in fat mass is similar to what was observed in a prospective study of 75 overweight and obese type 2 diabetic patients, where at week 24 fat mass loss was 16.5% in the bimagrumab group compared to a 0.8% increase in the placebo group. In this study, by week 48 fat mass in the bimagrumab group had decreased by 20.5% while lean mass increased by 3.6%, with no change in either parameter in the placebo group.
"This analysis further underscores the potential of bimagrumab to transform the lives of patients living with obesity by enabling substantial fat loss with the added unique feature of increasing muscle mass, resulting in significantly improved body composition," Klickstein said. "Furthermore, unlike other existing obesity treatments, bimagrumab demonstrates similar activity in both diabetic and non-diabetic patient populations."
Bimagrumab will enter a Phase 2b study later this year in non-diabetic patients with obesity to evaluate its safety and efficacy both as a monotherapy and when co-administered with an incretin agonist therapy.
"While incretin therapies have demonstrated their effectiveness in driving weight loss, this comes at the expense of significant lean mass loss," Klickstein said. "We believe that co-administering bimagrumab may prevent this undesirable effect while amplifying overall fat loss."
The objective of the Phase 2b combination study will be to demonstrate the potential of bimagrumab to become a novel treatment option that helps patients with obesity lose substantial fat mass without compromising muscle mass or function.
Bimagrumab is a first-in-class, fully human IgG1/λ monoclonal antibody to activin type II receptors that blocks binding of ligands including myostatin, activins and GDF11. 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 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 that is transforming the experience of living for people with cardiometabolic disease. The company's lead asset, bimagrumab, is being advanced in a Phase 2b study in obesity, with the goal of helping adults with obesity achieve and maintain both substantial fat loss and a healthy body composition. For more information, please visit https://www.versanisbio.com/.
SOURCE Versanis Bio