Rhythm Pharmaceuticals is advancing its oral obesity drug bivamelagon to Phase III studies after it significantly reduced body mass index (BMI) in all three doses.
The Phase II study (NCT06046443) was investigating the therapy in patients with acquired hypothalamic obesity. Patients can also remain on the open-label extension of the study for 52 weeks.
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Topline data from the study has shown a 9.3% reduction in BMI in the high dose cohort (600mg), a 7.7% reduction in the medium dose cohort (400mg) and a 2.7% reduction in the low dose cohort (200mg) after 14 weeks. The placebo group saw a 2.2% increase in BMI.
The BMI reduction achieved by bivamelagon, an investigational oral melanocortin-4 receptor (MC4R) agonist, was consistent with BMI reductions achieved with Rhythm’s Imcivree (setmelanotide) therapy in similar patient populations in past trials.
Patients in the high and medium dose cohorts achieved a mean reduction greater than 2.8 points in their ‘most’ hunger scores measured on a TEN-point scale. Patients in the low-dose arm achieved a mean reduction of 2.1 points, while patients on placebo therapy reported a mean increase of 0.8 points.
The therapy also remained safe and tolerable in the study, consistent with other therapies in the MC4R agonism.
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By GlobalDataOn 9 July, Rhythm’s stock, listed on the Nasdaq exchange, closed 36.63% higher at $89.00 compared to an 8 July close of $65.14. Rhythm Pharmaceuticals has a market cap of £5.66bn.
Rhythm Pharmaceuticals’ CEO Dr David Meeker said: “We are excited by these results, which suggest bivamelagon has the potential to treat patients with acquired hypothalamic obesity, and has established an appropriate dose range for future clinical evaluation. Unlike in studies evaluating general obesity, once again we observed no placebo effect in this study.”
Meeker said that Rhythm will be speaking with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the Phase III trial design of bivamelagon.
Rhythm in-licensed bivamelagon from LG Chem in January 2024, with a $40m upfront payment and $20m in equity. Rhythm will also provide LG Chem with an additional $205m upon reaching certain regulatory and sales milestones.
Oral obesity sector heats up
This is yet another positive readout for an oral obesity medicine. Last month, Novo Nordisk’s amycretin, which is available in both subcutaneous and oral dosing, showed weight loss of up to 22% after 36 weeks, with the drug set to advance to Phase III.
Furthest ahead in the game is Eli Lilly, with its oral glucagon-like peptide-1 receptor agonist (GLP-1RA) orforglipron having shown benefit in a Phase III trial. Lilly plans to submit the therapy for approval by the end of 2025, with a type 2 diabetes application to follow in 2026.
GlobalData predicts the obesity market will continue to grow as new products are released, reaching $206.5bn in 2031.
GlobalData is the parent company of Clinical Trials Arena.
