Idorsia is shutting down its plans for a binge eating disorder therapy after disappointing study results.
Results from the Swiss biopharma's phase 2a study showed that the treatment, ACT-539313, failed to reduce the number of binge eating days per week in adults with moderate to severe binge eating disorder. A binge eating day is defined as a day with at least one confirmed binge eating episode.
Idorsia’s drug is a brain-penetrating, selective orexin 1 receptor antagonist. It showed potential in preclinical studies with animal models and during phase 1 trials, but could not stand up in later trials. In phase 1 trials, patients received either a single dose of up to 400mg or two doses per day that were 200mg each over a 10 day period. The phase 2a study lowered the dosing amount with a single 100mg dose given to patients twice a day over a 12 week period.
All phases of the study showed the drug was well tolerated by patients.
The team at Idorsia is “disappointed in the result,” said Alberto Gimona, head of global clinical development at the company. Idorsia will publish the results of the study in the future, it said. For now, ACT-539313 is still listed among the company's pipeline products, with the target indication "under evaluation."
Eating disorders are among many mental health disorders that lack tailored treatments. An analysis of mental health therapeutics trial data from 2010-2021 found that over 70% of the more than 3,000 trials launched in the mental health space were focused on depression, schizophrenia and anxiety, which means patients with eating disorders are left with few options designed specifically for their diseases.