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Bristol Myers Squibb (NYSE:BMY) announced Saturday that its experimental schizophrenia therapy KarXT, acquired as part of its recent Karuna Therapeutics buyout, indicated a well-tolerated safety profile in a Phase 3 program.
Citing data from its EMERGENT-4 and EMERGENT-5 trials, the Princeton, New Jersey-based pharma giant said KarXT was not associated with weight gain, a side effect commonly seen with antipsychotic use in schizophrenia.
According to the August data cut based on 718 patients, 65% of trial participants witnessed a weight reduction compared to 4% who gained weight over 52 weeks.
The average weight reduction stood at 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 prior trial data, and 53% of patients discontinued the treatment due to issues such as treatment-related adverse events (15%) and withdrawn participation (19%).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 U.S. for schizophrenia in adults, with a decision expected by September. Efficacy and long-term safety data from the company’s EMERGENT program backed its marketing application. Bristol Myers (BMY) acquired Karuna in March following a $14B deal.