AbbVie's shares experienced a significant drop following the failure of emraclidine in two Phase 2 clinical trials, EMPOWER 1 and 2, designed to evaluate its efficacy in treating schizophrenia. The drug, acquired as part of AbbVie's $8.7 billion acquisition of Cerevel Therapeutics, did not meet its primary endpoint of demonstrating improvement over placebo as measured by the Positive and Negative Syndrome Scale (PANSS) total score.
The failure casts doubt on AbbVie's investment in Cerevel, made in anticipation of positive data readouts. AbbVie has stated that it will analyze the data to determine the future of the emraclidine program. Emraclidine is a selective muscarinic M4 receptor-positive allosteric modulator (PAM) that was designed to have a limited effect on dopamine neurotransmission, a mechanism thought to improve the tolerability issues associated with current antipsychotic medications.
The setback for AbbVie could prove advantageous for Bristol-Myers Squibb (BMS), which recently received FDA approval for Cobenfy (xanomeline tartrate/trospium chloride) for schizophrenia, marking a return to new-mechanism therapies for the disorder after a decade-long gap. Following AbbVie's announcement, BMS shares saw a rise of nearly 12%.
Cobenfy is a combination of a muscarinic M1 and M4 agonist with a muscarinic antagonist included to reduce side effects. BMS acquired Cobenfy through its $14 billion acquisition of Karuna Therapeutics last December. Neurocrine Biosciences' selective muscarinic M4 agonist, NBI-1117568, also showed positive results in a Phase 2 schizophrenia study in August, further positioning emraclidine as an outlier in its class.
AbbVie's acquisition of Cerevel was part of a broader strategy to diversify its pipeline in anticipation of the loss of patent protection for its blockbuster drug Humira (adalimumab). The Cerevel deal followed AbbVie's $10.1 billion acquisition of antibody-drug conjugate developer ImmunoGen.
Richard Gonzalez, AbbVie's chief executive, previously stated that Cerevel's pipeline had "multibillion-dollar sales potential" and would provide "a significant growth opportunity well into the next decade." Roopal Thakkar, AbbVie's chief scientific officer, reiterated the company's commitment to developing innovative therapies for psychiatric and neurological disorders.
