The company has announced that DAYBREAKi, the first phase III study for Lu AF35700, an investigational, novel, once-daily, oral antipsychotic drug candidate for the potential treatment of treatment-resistant schizophrenia (TRS), did not meet the primary endpoint of statistical superiority vs conventional therapy.
Lu AF35700 was safe and generally well-tolerated in the study with no unexpected adverse events reported.
“TRS constitutes the highest burden of disease within schizophrenia for patients, their families and society and we had with Lu AF35700 hoped to show superiority against conventional therapy”, says Anders Gersel Pedersen, Executive Vice President, Research and Development at Lundbeck; “this is a setback for patients with schizophrenia, but we will continue to advance our pipeline of innovative therapies to meet the needs of patients suffering from psychiatric and neurological diseases.”
About the study
DAYBREAK was a multinational, double-blind, randomized, active-controlled phase III study that evaluated the antipsychotic efficacy, safety and tolerability of Lu AF35700 compared to an active-controlled arm over ten weeks in 964 patients with TRS.
About Lu AF35700
Lu AF35700 is an antagonist at dopaminergic, serotonergic, and α adrenergic receptors. Unlike all currently available antipsychotics, Lu AF35700 has higher affinity for the human dopamine D1 receptor than it has for the human dopamine D2 receptor. In TRS, the higher ratio of dopamine D1 vs. D2 receptor activity is hypothesized to result in a beneficial efficacy profile and a tolerability profile without the troublesome side effects associated with extensive dopamine D2receptor blockade, such as extrapyramidal symptoms.
In November 2015, FDA granted Fast Track designation for Lu AF35700.
Photo of Anders Gersel Pedersen: Lundbeck