Rhythm Pharmaceuticals (RYTM) said Monday the phase 3 trial evaluating its experimental drug, setmelanotide, to treat acquired hypothalamic obesity in adult and pediatric patients met its primary endpoint, sending the shares up 5% in recent premarket activity.
The company said the drug showed a statistically significant and clinically meaningful reduction in body mass index in patients treated with setmelanotide compared to placebo.
The drugmaker said that patients on setmelanotide therapy showed a mean body mass index reduction of 16.5% reduction, compared to an increase of 3.3% for placebo after 52 weeks.
It added that adult patients achieved a 19.2% placebo-adjusted body mass index reduction at 52 weeks.
The company also said the therapy showed clinically meaningful improvements across key secondary endpoints.
Rhythm Pharmaceuticals said it plans to file for marketing approval of therapy in the US and EU by Q3.
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