Rhythm Pharmaceuticals (NASDAQ:RYTM) announces positive preliminary data from a Phase 2 clinical trial evaluating once-weekly setmelanotide in healthy obese volunteers.
Participants who received weekly injections showed comparable weight loss to those who received daily treatment over a 12-week period.
Both formulations were safe and well-tolerated. All adverse events observed were considered mild by investigators.
On the pharmacokinetic front, mean plasma trough drug concentrations in patients receiving 20 mg and 30 mg each week were similar to 3 mg dosed daily, although the trough concentration for the 30 mg dose was actually greater.
The company plans to discuss next steps with the FDA.
The company completed its U.S. marketing application about three months ago seeking approval to use setmelanotide to treat pro-opiomelanocortin deficiency obesity and leptin receptor deficiency obesity.
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