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Investing.com -- Rhythm Pharmaceuticals Inc (NASDAQ:RYTM) stock surged 10% after the company announced positive topline results from its Phase 2 trial evaluating bivamelagon, an investigational oral melanocortin-4 receptor agonist, in patients with acquired hypothalamic obesity.
The biopharmaceutical company reported that bivamelagon achieved statistically significant and clinically meaningful reductions in body mass index (BMI) at 14 weeks of treatment. The 600mg dose cohort showed a 9.3% BMI reduction from baseline, while the 400mg and 200mg cohorts demonstrated 7.7% and 2.7% reductions, respectively. In contrast, patients in the placebo group experienced a 2.2% increase in BMI over the same period.
"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," said David Meeker, Chair, CEO and President of Rhythm Pharmaceuticals.
In a post-hoc analysis comparing the Phase 2 results to prior setmelanotide trials, bivamelagon demonstrated comparable BMI reductions. The 400mg and 600mg dose groups achieved mean BMI reductions of 8.8% and 10.1% at 14 weeks, similar to the 9.7% and 10.5% reductions seen with setmelanotide at 12 and 16 weeks, respectively.
Patients also reported meaningful reductions in hunger scores. The 600mg and 400mg cohorts achieved a mean reduction greater than 2.8 points in their ’most’ hunger scores measured on a 10-point scale, while the 200mg arm saw a 2.1-point reduction. Placebo patients reported a 0.8-point increase in hunger.
The drug demonstrated safety and tolerability results consistent with its mechanism of action. Common adverse events included mild episodes of diarrhea and nausea, with one patient discontinuing therapy due to a serious adverse event.
Rhythm plans to seek regulatory input on a Phase 3 trial design, requesting meetings with both the FDA and European regulators while refining the drug formulation to potentially improve tolerability.
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