Bristol Myers Squibb & Co (NYSE:BMY) on Tuesday released topline results from the Phase 3 ARISE trial evaluating the efficacy and safety of Cobenfy (xanomeline and trospium chloride) as an adjunctive treatment to atypical antipsychotics in adults with inadequately controlled symptoms of schizophrenia.
In the Phase 3 trial, adjunctive Cobenfy treatment demonstrated a 2.0-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo with an atypical antipsychotic at Week 6, which did not reach the threshold for statistical significance for the primary endpoint (P = 0.11).
PANSS is used to assess the severity of positive and negative symptoms. It measures symptoms like hallucinations, delusions, and disorganized thinking, as well as negative symptoms like blunted affect and social withdrawal.
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Preliminary analyses suggest that Cobenfy as an adjunctive treatment to an atypical antipsychotic was associated with improvements in symptoms of schizophrenia compared to placebo plus an atypical antipsychotic for certain patients.
In a post-hoc subgroup analysis, there was a notable difference in response between subjects treated with risperidone as a background therapy compared with the remaining subjects treated with other background antipsychotics (non-risperidone).
Cobenfy's safety and tolerability profile as an adjunctive treatment was consistent with previous monotherapy trials.
Bristol Myers Squibb will complete a full evaluation of the Phase 3 trial data and intends to present detailed results at an upcoming medical conference.
In September 2024, the FDA approved Cobenfy, an oral medication for schizophrenia in adults.
Data from the EMERGENT clinical program supported the FDA approval of Cobenfy. In Phase 3 EMERGENT-2 and EMERGENT-3 trials, Cobenfy met its primary endpoint, demonstrating statistically significant reductions of schizophrenia symptoms compared to placebo from baseline to week five.
William Blair viewed "the ARISE trial as one that could accelerate the uptake of Cobenfy overall, increasing physician confidence in the adjunctive setting ahead of their own personalized approaches."
Even though this setback might lower the chances of strong short-term results, Analyst Matt Phipps still sees a big long-term potential for Cobenfy, with estimated global sales reaching $3.7 billion for schizophrenia.
Bristol is expected to report first-quarter earnings on Thursday, April 24 and it is expected management to provide additional details on the study's impact to the launch curve for Cobenfy and longer-term opportunity.
"The opportunity in Alzheimer's disease psychosis is the next key readout for Cobenfy, where we see significant market opportunity assuming clinical success and a tolerable safety profile," analyst Phipps writes.
In November 2024, AbbVie Inc (NYSE:ABBV) stock plunged after two trials investigating emraclidine as a once-daily, oral monotherapy treatment for adults with schizophrenia failed two Phase 2 trials.
The studies did not meet their primary endpoint of showing a statistically significant improvement in the change from baseline in the PANSS total score compared to the placebo group at week 6.
Last year, Leerink analyst estimated the potential for peak Cobenfy sales of over $10 billion if it succeeds in additional indications since Eli Lilly And Co's (NYSE:LLY) Zyprexa generated $5 billion in peak revenue in 2010 at much lower prices.
Price Action: BMY stock is down 2.95% at $48.35 at the last check on Wednesday.
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