AbbVie announces that its two phase II EMPOWER trials for emraclidine in schizophrenia did not meet their primary endpoint
AbbVie announces that its two Phase II EMPOWER trials investigating emraclidine as a once-daily, oral monotherapy treatment for adults with schizophrenia who are experiencing an acute exacerbation of psychotic symptoms, did not meet their primary endpoint of showing a statistically significant reduction (improvement) in the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score compared to the placebo group at week 6
"While we are disappointed with the results, we are continuing to analyze the data to determine next steps," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "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."
In the EMPOWER trials, emraclidine was well-tolerated with a safety profile comparable to that observed in the Phase Ib trial. The most commonly reported adverse events in EMPOWER-1 and EMPOWER-2, respectively, were headache (9.4% and 10.8% in placebo, 14.1% in EMPOWER-1 10mg and 14.6% in EMPOWER-2 15mg, and 13.2% and 13.0% in 30mg), dry mouth (2.3% and 0.8% in placebo, 3.9% in EMPOWER-1 10mg and 0.8% in EMPOWER-2 15mg, and 9.3% and 5.3% in 30mg), and dyspepsia (3.1% and 1.5% in placebo, 3.9% in EMPOWER-1 10mg, and 3.1% in EMPOWER-2 15mg, and 7.8% and 2.3% in 30mg).
The EMPOWER clinical development program evaluated emraclidine in patients with schizophrenia who are experiencing an acute exacerbation in two adequately-powered, placebo-controlled Phase II trials, known as EMPOWER-1 (NCT05227690) and EMPOWER-2 (NCT05227703). The Phase II program was designed to study multiple dosing options to enable the full exploration of the therapeutic dose range for emraclidine.
The program also includes a 52-week open label extension trial EMPOWER-3 (NCT05443724) evaluating emraclidine in people living with schizophrenia who have stable symptoms and are not currently experiencing an acute exacerbation of psychotic symptoms.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
2 mins