Versanis Bio Advances Former Novartis Muscle-Wasting Drug Bimagrumab into Obesity Therapy with New IND Filing

Compiled and translated by丨Tom Li

Versanis Bio recently announced that it will repurpose bimagrumab, a drug previously developed by Novartis to address muscle loss, into a treatment for obesity.

Novartis's bimagrumab is a monoclonal antibody targeting the activin type II receptor (ActRII) that blocks the binding of ligands including activin A and myostatin, thereby modulating skeletal muscle growth. Backed by Atlas Venture and Medicxi, Versanis Bio recently announced that, following licensing from Novartis, it is exploring the potential of developing bimagrumab as an anti-obesity therapeutic.

As early as 2013, the drug was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of sporadic inclusion body myositis (sIBM). In 2019, Novartis further discovered in clinical trials that the drug could reduce body weight in adult patients with type 2 diabetes who were overweight or obese. In January 2020, Novartis released data from a small Phase II study on bimagrumab, once again confirming the drug's potential for weight loss.

This double-blind, placebo-controlled, 48-week randomized clinical trial was conducted among adults with type 2 diabetes at nine sites across the United States and the United Kingdom. Participants had a body mass index (BMI) of 28 to 40 kg/m² and glycated hemoglobin (HbA1c) levels between 6.5% and 10.0%. Over the 48-week period, treatment with bimagrumab combined with ActRII blockade significantly reduced total fat mass (FM) by 20.5% and increased lean mass (LM) by 3.6% in overweight or obese patients with type 2 diabetes.

Versanis stated that throughout the clinical development of the drug, treatment with bimagrumab has "consistently and effectively induced a significant reduction in fat mass without causing a substantial loss of lean body mass, while also improving patients' HbA1c levels and other cardiometabolic parameters." Therefore, Versanis decided to initiate a Phase II clinical trial of bimagrumab for the treatment of obesity, building on Novartis's previous research. In August 2021, Versanis Bio announced the completion of a $70 million Series A financing round, the proceeds of which will be used to advance the clinical development of bimagrumab, an activin receptor type II antagonist.

Previously, the U.S. Centers for Disease Control and Prevention (CDC) reported that the national obesity rate in the United States stands at 42%. Given the close association between obesity and various diseases (such as heart disease, diabetes, and certain types of cancer), it also leads to higher medical expenditures for individuals. According to data from the U.S. CDC, the average medical expenses for obese individuals are approximately $1,429 higher than those for people with a normal weight.

Although obesity prevalence has become a global public health issue and the number of patients with obesity continues to rise, currently fewer than 1% of obese patients receive pharmacological treatment, and the global obesity drug market size stands at only approximately USD 1.3 billion. Analysts project that by 2022, the market is expected to reach USD 3.44 billion, expanding at a compound annual growth rate (CAGR) of 27.5%. Over the next decade, the growth of the weight-loss drug market will be primarily driven by GLP-1 receptor agonists such as liraglutide. Furthermore, semaglutide, benaglutide, and tirzepatide, which are currently in late-stage clinical trials, also hold substantial market potential.

Reference Source:

1.Startup Runs with Old Novartis Muscle Loss Drug to Fight Obesity

2.Versanis Bio unveils $70M and a Novartis drug ready for Phase 2 test in obesity