Bristol Myers Squibb (BMS) has announced new interim data from the Phase III EMERGENT-4 open-label extension trial where KarXT (xanomeline-trospium) demonstrated reduction in symptoms in adults with schizophrenia.
The outpatient, 52-week trial evaluated the long-term safety, tolerability, and efficacy of the muscarinic antipsychotic in patients who had completed the treatment period of either Phase III EMERGENT-2 or EMERGENT-3 trials.
The interim analysis included 110 patients, with 29 completing a full year of treatment.
Results indicated that KarXT was associated with a significant improvement in schizophrenia symptoms, as measured by the Positive and Negative Syndrome Scale (PANSS) total score, with more than 75% of the subjects showing >30% symptom improvement.
A mean 1.7-point change in Clinical Global Impression-Severity (CGI-S) score from baseline indicating a shift from ‘markedly ill’ to ‘moderately’ or ‘mildly’ ill after one year was reported in subjects who received the antipsychotic.
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These improvements persisted throughout the 52-week trial, irrespective of initial treatment with KarXT or placebo.
Patients previously on placebo experienced significant symptom improvements within two weeks of starting KarXT treatment.
After four weeks, their PANSS total scores were comparable to those who had received KarXT from the start.
Additionally, KarXT had a favourable impact on weight and metabolic parameters, with most patients experiencing stability or improvements over the treatment period.
KarXT’s side effect profile remained in line with prior trials, without substantial changes in prolactin levels or movement disorder scale scores.
BMS Immunology, Cardiovascular and Neuroscience development senior vice-president and head Roland Chen said: “We are pleased to see a continued and consistent meaningful reduction in symptoms of schizophrenia across 52 weeks in an outpatient setting, beyond what was seen in the short-term, in-patient five-week trials (EMERGENT-2 and EMERGENT-3).
“We look forward to continued conversations with the FDA and to sharing additional data from the EMERGENT programme later this year.”
The latest development comes after the company reported that its Phase III KRYSTAL-12 trial of KRAZATI (adagrasib) for treating non-small cell lung cancer (NSCLC) with KRASG12C mutations met key endpoints.
