Rhythm Pharmaceuticals Inc (NASDAQ:RYTM) saw its stock rise by 10% after unveiling encouraging topline results from its Phase 2 clinical trial assessing bivamelagon, a novel oral melanocortin-4 receptor agonist, in patients suffering from acquired hypothalamic obesity.
The biopharma company revealed that bivamelagon produced statistically significant and clinically meaningful decreases in body mass index (BMI) after 14 weeks of treatment. Patients receiving the 600mg dose experienced a 9.3% reduction in BMI compared to baseline, while the 400mg and 200mg groups showed reductions of 7.7% and 2.7%, respectively. In contrast, the placebo group’s BMI increased by 2.2% during the same timeframe.
“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,” stated David Meeker, Chair, CEO and President of Rhythm Pharmaceuticals.
A post-hoc comparison of these Phase 2 outcomes with previous setmelanotide trials indicated similar BMI reductions. The 400mg and 600mg doses of bivamelagon led to mean BMI declines of 8.8% and 10.1% at 14 weeks, closely mirroring the 9.7% and 10.5% reductions observed with setmelanotide at 12 and 16 weeks, respectively.
Patients also reported notable decreases in hunger levels. Those in the 600mg and 400mg groups saw an average drop of more than 2.8 points on a 10-point hunger scale, while the 200mg group experienced a 2.1-point reduction. By contrast, hunger scores rose by 0.8 points among placebo recipients.
The medication demonstrated safety and tolerability consistent with its mechanism, with common side effects including mild diarrhea and nausea. One participant discontinued treatment due to a serious adverse event.
Looking ahead, Rhythm intends to seek guidance from regulatory bodies for Phase 3 trial design, scheduling meetings with both the FDA and European authorities, while working to optimize the drug formulation to enhance tolerability.
Rhythm Pharmaceuticals stock price
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