Rhythm Pharmaceuticals (NASDAQ:RYTM) said its medicine setmelanotide helped reduce Body Mass Index (BMI) in patients with severe obesity and hyperphagia (excessive hunger) in people living with hypothalamic obesity as per interim data from a phase 2 trial.
Hypothalamic obesity is caused when the hypothalamus — part of the brain that makes hormones which control functions such as sleep, body temperature, and hunger — does not function normally.
The company said 11 patients were evaluable, including nine patients who completed 16 weeks of treatment and two who discontinued early due to treatment-related adverse events.
Data from an interim analysis for the 11 patients showed -17.2% mean percentage change in BMI (range: -37.2 percent, -6.7 percent). -15.8% average change in body weight from baseline weight of 107.1 kg (range, 39.0 kg, 141.4 kg). -15.9 kg (range -28.2 kg, -6.7 kg) average weight loss from baseline, Rhythm said in a July 12 press release.
Data from the nine patients showed an average 19.5% change in BMI (range: -37.2 percent, -10 percent). Average -17.8% change in body weight from baseline weight of 107.8 kg (range: 39 kg, 141.4 kg). -17.8 kg (range: -28.2 kg, -9.5 kg) average weight loss from baseline.
The company added that setmelanotide also achieved a meaningful reduction in hunger scores, wherein average change in hunger score for patients older than 12 years old who completed 16 weeks on therapy (n=7) was -2.7 on a scale of 1-10, with 10 being most hungry.
Rhythm said setmelanotide was seen to be generally well tolerated and the most frequently reported treatment-emergent adverse events included nausea, vomiting, COVID-19, diarrhea, injection site reaction and abdominal pain.
The company plans to proceed to a phase 3 trial following consultation with regulatory agencies.
RYTM +8.53% to $5.09 premarket July 12.