AbbVie announced that a pair of phase 2 trials investigating emraclidine as a once-daily oral treatment for adults with schizophrenia who are experiencing an acute exacerbation of psychotic symptoms failed to meet their primary endpoints.
In the two EMPOWER trials, emraclidine as a monotherapy failed to show a statistically significant reduction (improvement) in the change from baseline in the Positive and Negative Syndrome Scale score — a rating system used to assess the severity of symptoms in schizophrenia patients — at week 6.
AbbVie picked up emraclidine, a potential novel M4-selective positive allosteric modulator (PAM), through its $8.7 billion acquisition of Cerevel Therapeutics that closed back in August. The drug is designed to reduce excess dopamine signaling in the striatum without blocking dopamine type 2 receptors. It was thought that by selectively targeting M4 receptors, emraclidine had the potential to reduce psychotic symptoms without interfering with dopamine, serotonin and/or histamine receptors, eliminating many of the side effects of current antipsychotics.
Bristol Myers Squibb beat AbbVie to the FDA finish line back in September when its schizophrenia drug, Cobenfy, became the first new drug for the disease in more than 30 years. Cobenfy treats schizophrenia by selectively targeting M1 and M4 receptors in the brain without blocking D2 receptors.
Now, AbbVie says it will continue to analyze the data to determine next steps for emraclidine. The drug is also in phase 1 for Alzheimer's disease psychosis with FDA Fast Track designation.