BMS posts long-term safety, efficacy data for newly gained schizophrenia candidate
07 Apr 2024
Clinical ResultPhase 3Acquisition
With the Karuna Therapeutics takeover officially closed as of last month, Bristol Myers Squibb shared updated long-term data on Saturday for the main asset it gained through the $14-billion acquisition: experimental schizophrenia treatment KarXT (xanomeline-trospium).
Bristol Myers Squibb presented one-year safety and efficacy data at the annual congress of the Schizophrenia International Research Society (SIRS), demonstrating that the dual agonist of M1 and M4 muscarinic receptors continued to improve symptoms and largely avoided some of the metabolic side effects seen with antipsychotics.
The data are a welcome sight ahead of an expected September decision from the FDA. In the Phase III EMERGENT-4 open-label extension study, patients saw an average reduction of 33.3 points from baseline, as measured by the Positive and Negative Syndrome Scale (PANSS) total score, with about three-quarters achieving a greater than 30% improvement.
The study enrolled 110 people with schizophrenia who had completed one of two previous five-week Phase III trials, EMERGENT-2 or EMERGENT-3; at the data cutoff, 29 participants had received KarXT for one year. Those earlier studies reported average PANSS reductions of 9.6 points and 8.4 points, respectively.
Additionally, according to average patient scores on the Clinical Global Impression-Severity (CGI-S) scale, those who received KarXT shifted from “markedly ill” at baseline to “moderately” or “mildly” ill at the one-year mark.
Weight loss high note
The pharma also shared a pooled safety analysis of EMERGENT-4 along with fellow open-label, 52-week study EMERGENT-5, which combined included 718 patients who received at least one dose of KarXT, with 134 of those having taken the treatment for at least one year.
According to Christoph Correll – professor of psychiatry and molecular medicine at Hofstra/Northwell’s Donald and Barbara Zucker School of Medicine and medical director in the department of psychiatry at Zucker Hillside Hospital – muscarinic receptor agonistsmuscarinic receptor agonists like KarXT might have a favourable safety profile when compared with antipsychotics, which have historically led to five adverse effects that reduce quality of life: weight gain, metabolic prolactin elevation, neuromotor side effects, sexual side effects and sedation. For more, see KOL Views Q&A: Leading psychiatrist sees a muscarinic revolution coming in schizophrenia and beyond.
Not only did the long-term safety data show no association between KarXT and weight gain, the treatment actually helped with weight loss. About 65% of patients experienced an overall reduction in weight, and those who completed one year of treatment saw an average loss of 2.6kg.
“It is promising to see that over one year of treatment, KarXT was not associated with burdensome side effects, specifically weight gain and metabolic dysfunction, as well as extrapyramidal symptoms, which underscores its potential to provide a meaningful and differentiated option for people living with schizophrenia,” said Roland Chen, head of immunology, cardiovascular and neuroscience development at Bristol Myers Squibb.
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