Bristol Myers' $14B Bet On Schizophrenia - Drug Cuts Symptoms Without Common Side Effect Of Weight Gain Associated With Other Antipsychotics

Saturday, Bristol Myers Squibb & Co BMY released interim long-term safety, tolerability, and metabolic outcomes data from its Phase 3 EMERGENT program evaluating KarXT (xanomeline-trospium) 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. Most patients experienced stability or improvements in key metabolic parameters over 52 weeks of treatment. 

The majority of patients (65%) experienced an overall reduction in weight, with more patients (18%) experiencing potentially clinically significant decreases in weight vs. 4% of patients experiencing weight increases. 

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.

KarXT was not associated with significant changes related to prolactin or clinically meaningful changes in movement disorder scale scores over 52 weeks.

Bristol Myers added KarXT to its portfolio with the acquisition of Karuna Therapeutics Inc. for $330.00 per share in cash, for a total equity value of $14.0 billion, or $12.7 billion net of estimated cash acquired. 

Concurrently, Bristol Myers shared new interim results from the Phase 3 EMERGENT-4 Phase 3 open-label extension trial of KarXT. 

In the interim analysis, KarXT was associated with significant improvement in symptoms of schizophrenia across all efficacy measures at 52 weeks. 

At the end of the open-label extension, more than 75% of participants achieved >30% improvement in symptoms, with an average reduction of 33.3 points from baseline (98.4), as measured by the Positive and Negative Syndrome Scale total score, a scale used for measuring symptom severity of patients with schizophrenia.

In addition, participants had a mean 1.7-point change in Clinical Global Impression-Severity score from baseline (5.2), representing an average shift from ‘markedly ill’ at baseline to ‘moderately’ or ‘mildly’ ill at one year.

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. 

Price Action: BMY shares are down 0.14% at $51.26 on the last check Monday.

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