AbbVie's stock experienced a significant drop of over 12% after its investigational anti-psychotic drug, emraclidine, failed to meet its primary endpoints in Phase II clinical trials for the treatment of schizophrenia. The drug was being evaluated in two randomized, double-blind, placebo-controlled Phase II trials, EMPOWER-1 (NCT05227690) and EMPOWER-2 (NCT05227703).
The trials, which enrolled a total of 372 patients, assessed the efficacy of emraclidine at different dosing levels (10mg or 30mg in EMPOWER-1 and 15mg and 30mg in EMPOWER-2) as a once-daily, oral monotherapy. The primary endpoint was the reduction in the Positive and Negative Syndrome Scale (PANSS) total score, a standard measure of schizophrenia symptoms.
Trial Results
In the EMPOWER-1 study, the PANSS scores were -14.7 (10mg) and -16 points (30mg) for emraclidine, compared to -13.5 in the placebo arm. Similarly, in EMPOWER-2, the PANSS scores were -18.5 (15mg) and -14.2 (30mg) for emraclidine, versus -16.1 in the placebo arm. These results indicate that emraclidine did not demonstrate a statistically significant improvement over placebo in reducing schizophrenia symptoms.
Roopal Thakkar, AbbVie’s executive vice president of research and development and chief scientific officer, stated, “While we are disappointed with the results, we are continuing to analyse the data to determine next steps. 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.”
Competitive Landscape
The failure of emraclidine contrasts with the progress of Bristol Myers Squibb (BMS) and their acquisition of Karuna Therapeutics. Karuna's lead asset, KarXT (xanomeline-trospium), an antipsychotic with a novel mechanism of action, has shown promising results. Recent data from a Phase III schizophrenia trial indicated that KarXT met its primary endpoint, demonstrating a significant 9.2-point reduction in the PANSS total score compared to placebo at week five.
Following AbbVie's announcement, BMS's stock price rose by over 11%, highlighting the competitive nature of the schizophrenia treatment market. KarXT is forecasted to reach an annual total of $2.81 billion in the US by 2033, according to GlobalData’s expiry model. The FDA has accepted Karuna’s New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults.
