Bristol Myers Squibb Presents New Interim Long-Term Efficacy Data from the EMERGENT-4 Trial Evaluating KarXT in Schizophrenia at the 2024 Annual Congress of the Schizophrenia International Research Society - Seite 2

Improvements in symptoms of schizophrenia continued throughout the 52-week trial regardless of whether participants were previously treated with KarXT or placebo during the acute trials. Prior to enrolling in the open-label extension, participants who previously received placebo in EMERGENT-2 and EMERGENT-3 had a significantly higher mean PANSS total score compared to those who received KarXT (placebo 86.5 vs. KarXT 76.1). When dosed with KarXT, the patients previously on placebo had significant improvements in symptoms within two weeks of treatment with KarXT. After four weeks, PANSS total scores were comparable between those who received KarXT or placebo in the acute trials.

“These interim data from EMERGENT-4 continue to validate the potential of KarXT in the long-term management of schizophrenia, with continued benefit across 52 weeks of treatment,” said Elan Cohen, Ph.D., principal investigator, CenExel Hassman Research Institute and investigator in the EMERGENT program. “The consistency of efficacy results across all EMERGENT clinical trial programs is encouraging and suggest KarXT could provide a differentiated treatment approach for people living with schizophrenia.”

In additional data presented at the congress, KarXT demonstrated a favorable impact on weight and long-term metabolic profile where most patients experienced stability or improvements on metabolic parameters over 52 weeks of treatment. In long-term trials, KarXT was generally well tolerated, with a side effect profile consistent with prior trials of KarXT in schizophrenia. KarXT was not associated with significant changes related to prolactin or clinically meaningful changes in movement disorder scale scores over 52 weeks (Oral Session: New Pharmacological Treatments and Assessments and Poster F74).

About KarXT
KarXT (xanomeline-trospium) is an investigational muscarinic antipsychotic in development for the treatment of schizophrenia and psychosis related to Alzheimer’s disease. Through its novel mechanism of action, KarXT acts as a dual M1/M4 muscarinic acetylcholine receptor agonist in the central nervous system, which is thought to improve positive, negative, and cognitive symptoms of schizophrenia. Unlike existing treatments, KarXT does not directly block dopamine receptors, representing a potential new approach to treating schizophrenia.