Bristol Myers Squibb (NYSE:BMY) announced Saturday that its investigational schizophrenia therapy KarXT, acquired as part of its recent acquisition of Karuna Therapeutics, indicated a well-tolerated safety profile in a Phase 3 program.
Citing data from the EMERGENT-4 and EMERGENT-5 studies, the Princeton, New The Jersey-based pharmaceutical giant said KarXT is not associated with weight gain, a side effect commonly seen with antipsychotic use in schizophrenia.
According to August data based on 718 patients, 65% of study participants experienced weight reduction compared to 4% who gained weight in 52 weeks.
The average weight reduction was 2.6kg in patients who completed a year on KarXT, signaling a new approach to schizophrenia therapy as the treatment does not directly block dopamine receptors.
The company said that KarXT’s side effect profile was consistent with data from previous studies, and that 53% of patients discontinued treatment due to issues such as treatment-related adverse events (15%) and withdrawal of participation (19%). Bristol Myers (BMY) shared the data during a presentation at an ongoing medical event in Europe.
KarXT is currently under review in the United States for schizophrenia in adults, with a decision expected by September. Long-term efficacy and safety data from the company’s EMERGENT program supported its marketing application. Bristol Myers (BMY) acquired Karuna in March following a $14 billion deal.