AbbVie’s Emraclidine Fails to Reduce Schizophrenia Symptoms Compared to Placebo

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Data from the Phase II EMPOWER trial demonstrated that as an oral monotherapy, AbbVie’s emraclidine did not reduce Positive and Negative Syndrome Scale (PANSS) total scores at six weeks compared to placebo. According to the company, it intends to continue analyzing the trial results before making a final decision moving forward.¹

"While we are disappointed with the results, we are continuing to analyze the data to determine next steps," said Roopal Thakkar, MD, EVP, research and development, chief scientific officer, AbbVie, in a press release. "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."

Investigators evaluated emraclidine in patients with schizophrenia who are experiencing an acute exacerbation in two placebo-controlled Phase II trials, which included EMPOWER-1 and EMPOWER-2. The purpose of the program was to study multiple dosing options to fully evaluate the therapeutic dose range for emraclidine. The EMPOWER program also included EMPOWER-3, a 52-week open label extension trial, which evaluated emraclidine in people living with schizophrenia who have stable symptoms and are not currently experiencing an acute exacerbation of psychotic symptoms. The primary endpoint of the study was the reduction of symptoms passed on PANSS total scores.

In EMPOWER-1, results demonstrated an 8.16-point change for patients in the placebo group. In the 10 mg emraclidine group and the 30 mg group, patients demonstrated point changes of 7.65 and 7.89, respectively. In EMPOWER-2, patients in the placebo group demonstrated an 8.22-point change from baseline, while the 10 mg and 30 mg groups demonstrated point changes of 8.49 and 7.75, respectively.

Despite the study not meeting its primary endpoint, a tolerable safety profile was reported, aligning with Phase Ib findings. Common adverse events (AEs) across all three groups included headache, dry mouth, and dyspepsia, with comparable rates between emraclidine and placebo groups.¹

According to the World Health Organization (WHO), schizophrenia affects around 24 million people globally, with a rate of one in 222 adults. Onset is most common during adolescence or in the early twenties, with onset tending to happen earlier in men compared to women. WHO statistics indicate that the majority of people with schizophrenia around the world are not receiving mental health care. Currently, it is estimated that 31.3% of people with psychosis receive specialist mental health care. Half of patients in mental health facilities have received a diagnosis of schizophrenia.²

According to the Treatment Advocacy Center, it was estimated that schizophrenia affected approximately 2.8 million adults in the United States over 18 years of age in 2020. Forty percent of patients in the United States remained untreated.³

The National Alliance on Mental Illness estimates that while the exact prevalence of schizophrenia is difficult to measure, the estimated range in the United States is between 0.25% and 0.64%. It is uncommon for a diagnosis to be received under 12 years of age or over 40 years of age. In addition to schizophrenia, it is not uncommon for patients to also suffer with major depressive disorder, post-traumatic stress disorder, obsessive-compulsive disorder, and a number of substance abuse disorders.⁴

References

1. AbbVie Provides Update on Phase 2 Results for Emraclidine in Schizophrenia. PR Newswire. November 11, 2024. Accessed November 11, 2024. https://www.prnewswire.com/news-releases/abbvie-provides-update-on-phase-2-results-for-emraclidine-in-schizophrenia-302301190.html

2. Schizophrenia. WHO. January 10, 2022. Accessed November 11, 2024. https://www.who.int/news-room/fact-sheets/detail/schizophrenia

3. Schizophrenia Fact Sheet. TAC. Accessed November 11, 2024. https://www.tac.org/reports_publications/schizophrenia-fact-sheet/#:~:text=Schizophrenia%20is%20a%20chronic%20and,States%20aged%2018%20or%20older.

4. Schizophrenia. NAMI. Accessed November 11, 2024. https://www.nami.org/about-mental-illness/mental-health-conditions/schizophrenia/