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AbbVie shares plunge over 12% after schizophrenia drug fails in Phase II trials

According to GlobalData's expiration model, Emraclidine is expected to reach total annual sales of $192 million in the United States by 2034. Photo credit: Valeriya Zankovych / Shutterstock.

AbbVie's stock price fell over 12% after Emraclidine, an antipsychotic drug in development for the treatment of schizophrenia, failed to meet its primary endpoints in the company's Phase II program.

The pharmaceutical giant evaluated the candidate in two randomized, double-blind, placebo-controlled Phase II studies, EMPOWER-1 (NCT05227690) and EMPOWER-2 (NCT05227703). Yesterday (November 11), the company announced that emraclidine failed to meet the primary endpoint of reduction in Positive and Negative Syndrome Scale (PANSS) total score in both studies.

AbbVie acquired Emraclidine, a potential novel M4-selective positive allosteric modulator (PAM) originally marketed by Cerevel Therapeutics, in an $8.7 billion acquisition of the Massachusetts-based biotech in August 2024.

The Phase II studies enrolled a total of 372 patients to evaluate multiple doses of emraclidine (10 mg or 30 mg in EMPOWER-1 and 15 mg and 30 mg in EMPOWER-2) as once-daily oral monotherapy to determine the optimal to determine the therapeutic dose range for schizophrenia patients who experience an acute increase in psychotic symptoms.

In the EMPOWER-1 trial, PANNS scores were -14.7 (10 mg) and -16 points (30 mg) versus -13.5 in the placebo arm. In EMPOWER-2, PANNS scores were -18.5 MB (15 mg) and -14.2 (30 mg) compared to -16.1 in the placebo arm.

Commenting on the study results, Roopal Thakkar, Executive Vice President of Research and Development and Chief Scientific Officer at AbbVie, said: “While we are disappointed with the results, we continue to analyze the data to determine next steps.

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“We are confident that our innovative pipeline will continue to provide patients with meaningful therapies, and we remain committed to finding better treatments for people with psychiatric and neurological disorders.”

Advantage, Bristol Myers Squibb?

Similar to AbbVie, Bristol Myers Squibb (BMS) took a similar path last year by signing a definitive acquisition agreement for Karuna Therapeutics in December 2023.

Through the acquisition, BMS gained control of Karuna's lead compound KarXT (xanomeline trospium), an antipsychotic with a novel mechanism of action (MoA) and differentiated efficacy and safety.

In contrast to AbbVie's problems, KarXT appears to be thriving. Zai Lab recently presented data from a Phase III study in schizophrenia showing that KarXT met its primary endpoint with a significant 9.2 point reduction in PANSS total score compared to placebo. in the fifth week.

Following AbbVie's announcement, BMS's stock price rose over 11% while its share price fell.

According to GlobalData's expiration model, KarXT is expected to reach total annual sales of $2.81 billion in the United States by 2033.

Karuna's New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults has been accepted for review by the US Food and Drug Administration (FDA).


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