Advertisement. Remove ads.
Rhythm Pharmaceuticals, Inc. (RYTM) on Wednesday announced that its drug Bivamelagon achieved statistically significant and clinically meaningful reductions in body mass index (BMI) in patients with acquired hypothalamic obesity in a mid-stage trial.
Rhythm’s shares were trading 31% higher at the time of writing.
The company said that Bivamelagon achieved as much as a 9.3% reduction from baseline in body mass index at 14 weeks of treatment. Patients also reported meaningful reduction in their ‘most’ hunger scores at 14 weeks on therapy as compared to placebo, the company said.
CEO David Meeker said that the company is excited by the results, which suggest Bivamelagon has the potential to treat patients with acquired hypothalamic obesity. Rhythm in-licensed Bivamelagon from LG Chem, Ltd in January 2024.
Acquired hypothalamic obesity is a rare form of obesity that occurs following damage to the hypothalamic region of the brain, which most frequently follows the growth or surgical removal of craniopharyngioma, astrocytoma, or other rare brain tumors.
Patients experience accelerated weight gain, a reduction in energy expenditure, and hyperphagia (a chronic pathological condition characterized by insatiable hunger, impaired satiety, and persistent abnormal food-seeking behaviors), leading to severe obesity within six to 12 months following tumor resection or other injury.
Rhythm now plans to seek input from U.S. and EU regulatory authorities on a late-stage trial design to advance Bivamelagon in acquired hypothalamic obesity. The company is also refining the formulation of Bivamelagon, potentially to improve tolerability ahead of initiating a late-stage trial, as one of the 28 patients in the mid-stage study discontinued therapy due to rectal bleeding.
Rhythm estimates there are 5,000 to 10,000 people living with hypothalamic obesity in the U.S., 5,000 to 8,000 people living with hypothalamic obesity in Japan, and 3,500 to 10,000 people living with hypothalamic obesity in the E.U.
On Stocktwits, retail sentiment around RYTM jumped from ‘bullish’ to ‘extremely bullish’ over the past 24 hours while message volume jumped from ‘high’ to ‘extremely high’ levels.
RYTM stock is up by about 52% this year and by about 90% over the past 12 months.
Read Next: Trump Slaps 30% Tariff On Iraq, Says It’s ‘Less Than What Is Needed’
For updates and corrections, email newsroom[at]stocktwits[dot]com.