AbbVie's experimental drug, emraclidine, a centerpiece of its nearly $9 billion acquisition of Cerevel Therapeutics, failed to meet its primary endpoints in two Phase 2 clinical trials for schizophrenia. The results, disclosed by AbbVie, led to a significant drop in the company's market value. The trials, which involved around 750 participants, evaluated the efficacy of three different doses of emraclidine against a placebo over a six-week period.
Trial Design and Results
The studies utilized a well-established scale to measure various schizophrenia symptoms, including both positive symptoms like hallucinations and excitement, and negative symptoms such as emotional withdrawal. Emraclidine, designed as a novel brain-balancing medication, did not demonstrate a statistically significant improvement over placebo in reducing these symptoms at any of the tested doses.
"While we are disappointed with the results, we are continuing to analyze the data to determine next steps," stated Roopal Thakkar, AbbVie’s chief scientific officer.
Strategic Implications for AbbVie
Despite the setback, AbbVie maintains that neuroscience remains a core focus area. The company recently announced a $1.4 billion investment in a startup developing an experimental Alzheimer’s treatment. Furthermore, AbbVie emphasizes the broader pipeline of drug programs acquired through the Cerevel acquisition, which includes multiple clinical-stage and preclinical candidates that complement its existing portfolio of brain medicines. This portfolio includes drugs like Botox, Vraylar (an antipsychotic), and Ubrelvy (a migraine medication), which generated nearly $6.5 billion in net revenue over the first nine months of the year.
Competitive Landscape
The failure of emraclidine could have positive implications for Bristol Myers Squibb (BMS) and its recently acquired drug, Cobenfy. Cobenfy, approved by the FDA in September, is an antipsychotic medication that has shown promise in treating schizophrenia with a different side effect profile than existing treatments. Olivia Brayer, an analyst at Cantor, suggests that emraclidine's failure removes a "major overhang" for Cobenfy, as its "biggest competitive threat in schizophrenia is no longer."
Market Reaction
Following the announcement of the trial results, AbbVie's shares experienced a significant decline. Conversely, Bristol Myers Squibb's shares saw an increase, reflecting the potential benefit to Cobenfy's market position. The market's reaction underscores the high stakes and competitive dynamics within the schizophrenia treatment landscape.