Versanis’ bimagrumab, first-in-class obesity therapy, enters Phase IIb of development

On January 12, Versanis Bio announced that enrollment had begun for its Phase IIb trial, BELIEVE (NCT05616013), which aims to study bimagrumab’s (BYM-338) efficacy and safety in the US, among other locations. Bimagrumab is of interest in the obesity space as it is a first-in-class therapy for obesity.

In a previous Phase II trial (NCT03005288), which studied the effect of bimagrumab in obese or overweight patients with type 2 diabetes, fat loss exceeding 20% was demonstrated by week 48 of the study, displaying efficacy comparable to the likes of Eli Lilly’s Mounjaro (tirzepatide), which is approved for type 2 diabetes and has currently received Fast Track designation for obesity. Mounjaro is anticipated to launch in the US later this year or by early 2024.

Bimagrumab is an activin receptor type 2B (ACVR2B or EC 2.7.11.30) antagonist that offers a unique mechanism of action within the obesity market. In addition to facilitating loss of fat, the Phase II trial also showed that a lean mass gain of 4.5% was observed in the study. Furthermore, bimagrumab is a long-acting therapy, thus significantly reducing the number of treatment days in comparison to many currently marketed and late-stage pipeline therapies. While tirzepatide requires weekly administration, bimagrumab is administered once every four weeks, which should have positive implications on patient compliance. However, its intravenous route of administration means that the treatment can only be administered in a hospital. Nonetheless, patients receiving the current standard of care, Novo Nordisk’s Wegovy (injectable semaglutide), are expected to self-administer treatment on a weekly basis. Furthermore, many patients with obesity have other comorbidities, so this reduction in the frequency of treatment days is all the more essential to this subset of patients in ameliorating compliance to treatment.

Key opinion leaders (KOLs) interviewed by GlobalData have noted that while bimagrumab’s intravenous route of administration will be an issue, among other factors such as its high cost, the therapy may be important to patients who have a high body mass index (BMI) and will likely serve as a tertiary therapy for patients who have exhausted other treatment options.

Despite its high price tag, bimagrumab’s unique features set it apart from currently marketed therapies. Provided its Phase IIb trial emulates the results exhibited in the Phase II trial, this new therapy may successfully penetrate the obesity market in the foreseeable future and provide further treatment options for patients who experience clinical benefits from currently marketed therapies.