AbbVie has announced that its two Phase 2 EMPOWER trials for an experimental schizophrenia drug, emraclidine, failed to meet the primary endpoint.
Emraclidine is a potential novel M4-selective positive allosteric modulator (PAM) being developed for schizophrenia and Alzheimer’s disease psychosis.
AbbVie gained rights to the asset through the acquisition of Cerevel Therapeutics, which closed in August 2024.
The EMPOWER clinical development programme evaluated the drug candidate in two Phase 2 trials, EMPOWER-1 and EMPOWER-2.
These trials were designed to explore multiple dosing options and identify the optimal therapeutic dose range.
Additionally, the programme includes EMPOWER-3, a 52-week open-label extension trial, studying emraclidine in stable schizophrenia patients not currently experiencing acute psychotic symptoms.
The two mid-stage studies assessed the drug as a once-daily oral treatment for schizophrenia in adults who are experiencing an acute exacerbation of psychotic symptoms.
The asset failed to lower symptom severity and showed no significant improvement in the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo at week six.
In the EMPOWER trials, emraclidine was well-tolerated, with a safety profile similar to the Phase 1b trial.
AbbVie chief scientific officer and research and development executive vice president Roopal Thakkar said: “While we are disappointed with the results, we are continuing to analyse the data to determine next steps.
“We would like to extend our gratitude to the study participants and their loved ones as well as to our network of clinical investigative sites for their participation in these trials.
“We are confident that our innovative pipeline will continue to bring meaningful therapies to patients, and we remain committed to finding better treatments for people living with psychiatric and neurological disorders.”
AbbVie stated that it is continuing to analyse the trial data to determine its next steps.
The latest update comes after Bristol Myers Squibb secured US Food and Drug Administration (FDA) approval for Cobenfy (xanomeline and trospium chloride) to treat schizophrenia in adults.
