Lundbeck announced a decision to discontinue a phase II proof of concept clinical study of Lu AF11167 in patients with schizophrenia who are experiencing persistent negative symptoms. The decision to stop the trial is based on the results of a futility interim analysis, which concluded that the trial is unlikely to achieve statistical significance on its primary endpoint, mean change from baseline to week 12 on the Brief Negative Symptom Scale (BNSS). The recommendation to stop the trial is not based on safety concerns. Lundbeck plans to submit the study results for scientific publication at a later date.
The primary objective of the phase II study was to evaluate the efficacy of negative symptoms of two doses of Lu AF11167 versus placebo as monotherapy in patients with schizophrenia and persistent, prominent negative symptoms. The secondary objective was to evaluate the efficacy of Lu AF11167 on patients’ functioning and the safety and tolerability of the compound. This 3-arm study was planned to randomize 240 patients (80 patients per arm) from various European countries.
About Lu AF11167
Lu AF11167 is a small molecule and a potent and selective inhibitor of the phosphodiesterase 10A enzyme (PDE10Ai). PDE10Ai modulates dopamine D1 and D2 receptor-mediated intraneuronal signaling without binding to these receptors. PDE10Ai is believed to reduce negative symptoms and to keep positive symptoms stabilized.
Schizophrenia is caused by an imbalance in the neurotransmitters facilitating the communication between neurons in the brain, leading to the perception (seeing/hearing/thinking) of things that are not real. The factors that create this imbalance are not fully understood. Negative symptoms, a diminution or absence of normal behaviors related to motivation and interest or expression, are a core component of schizophrenia, and they account for a large part of the long-term morbidity and poor functional outcome in patients with the disorder.