Bristol Myers presents new data from Phase 3 EMERGENT program evaluating KarXT

Bristol Myers Squibb announced interim long-term safety, tolerability and metabolic outcomes data from its Phase 3 EMERGENT program evaluating KarXT in adults with schizophrenia. The EMERGENT-4 and EMERGENT-5 trials are Phase 3, outpatient, 52-week, open-label trials evaluating the safety, tolerability, and efficacy of KarXT in adults with schizophrenia. At the time of the data cutoff of August 18, 2023, the interim pooled data analysis included 718 patients who received at least one dose of KarXT, with 134 patients having completed one year of treatment. In the pooled analysis, KarXT demonstrated a favorable impact on weight and long-term metabolic profile where most patients experienced stability or improvements on key metabolic parameters over 52 weeks of treatment. The majority of patients experienced an overall reduction in weight over the course of the trial, with more patients experiencing potentially clinically significant decreases in weight vs. 4% of patients experiencing increases in weight. In patients who completed 52 weeks of treatment with KarXT, an average reduction in weight of 2.6kg was observed, with a larger mean reduction in weight of 4.1kg observed in clinically obese patients. Total cholesterol, triglyceride and HbA1c levels did not meaningfully change over one year of treatment. In the long-term studies, KarXT was generally well-tolerated across 52 weeks of treatment, with a side effect profile consistent with prior trials of KarXT in schizophrenia. The overall discontinuation rate in the trial was 53% and primary reasons for discontinuation included withdrawn consent, treatment-related adverse events, participant lost to follow-up, and participant failed to adhere to protocol requirements. Across the long-term EMERGENT trials, 62% of participants reported at least one treatment-related adverse event. KarXT was not associated with significant changes related to prolactin or clinically meaningful changes in movement disorder scale scores over 52 weeks. In additional interim long-term data presented at the congress, KarXT was associated with significant improvements in symptoms of schizophrenia across all efficacy measures at 52 weeks in the EMERGENT-4 trial. Improvements in symptoms of schizophrenia continued throughout the open-label extension regardless of whether participants were previously treated with KarXT or placebo during the acute trials, EMERGENT-2 or EMERGENT-3.