The company initiates a phase II-study (proof of concept-study) with the compound Lu AF11167 to confirm its potential as treatment of patients with schizophrenia who are experiencing persistent negative symptoms.
Lu AF11167 represents a new approach to treat negative symptoms of schizophrenia, working by inhibiting the activity of the PDE10-enzyme in the brain. This affects the signaling of the neurotransmitter dopamine in a manner that may specifically improve negative symptoms while positive symptoms remain controlled. Lu AF11167 is invented by Lundbeck.
“We are pleased to advance the clinical development of Lu AF11167, which has the potential to improve the treatment of patients with schizophrenia who are experiencing persistent negative symptoms. We look forward to learn more about this potential in the proof of concept-study,” says Mads Dalsgaard, Senior Vice President, Clinical Development at Lundbeck.
About the study
The primary objective of the phase II study is to evaluate the efficacy on negative symptoms of two doses of Lu AF11167 versus placebo as monotherapy in patients with schizophrenia and persistent prominent negative symptoms.
The secondary objective will be to evaluate the efficacy of Lu AF11167 on patients’ functioning as well as the safety and tolerability of the compound. This 3-arm study will randomize a total of 240 patients (80 patients per arm) from various European countries.