hapabapa/iStock Editorial via Getty Images
Bristol-Myers Squibb (New York Stock Exchange:BMY) announced Saturday that its experimental schizophrenia therapy KarXT, acquired as part of its recent purchase of Karuna Therapeutics, indicated a well-tolerated safety profile in a Phase 3 program.
Citing data from their EMERGENT-4 and EMERGENT-5 trials, Princeton, New The Jersey-based pharmaceutical giant said KarXT was not associated with weight gain, a side effect commonly seen with the use of antipsychotics in schizophrenia.
According to the August data cut based on 718 patients, 65% of trial participants witnessed weight loss compared to 4% who gained weight over 52 weeks.
The average weight reduction was 2.6 kg in patients who completed one year of treatment with KarXT, indicating a new approach in schizophrenia therapy, as the treatment does not directly block dopamine receptors.
The company said KarXT's side effect profile was consistent with data from previous trials, with 53% of patients discontinuing treatment due to issues such as treatment-related adverse events (15%) and withdrawal from 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 US for schizophrenia in adults, with a decision expected in September. Long-term efficacy and safety data from the company's EMERGENT program supported its marketing application. Bristol Myers (BMY) acquired Karuna in March in a $14 billion deal.
