A clinical phase III multi-national study with approximately 1,000 patients has been initiated
Lu AF35700 has a novel pharmacological profile with predominant D1 vs. D2 dopamine receptor occupancy combined with high 5-HT6 receptor occupancy. The program follows demonstration of good safety profile in phase I trials in both healthy subjects and patients with schizophrenia
Lu AF35700 may become the first new pharmacotherapy in decades for patients with treatment resistant schizophrenia (TRS)
Patients with treatment resistant schizophrenia account for a significant part of the total health care costs associated with schizophrenia[i]
Valby, Denmark, 11 March 2016 - H. Lundbeck A/S (Lundbeck) today announced that the investigational compound Lu AF35700, a novel antipsychotic, is entering clinical phase III program.
Lundbeck is initiating the phase III program which is currently planned to consist of two pivotal trials. Two doses of Lu AF35700 (10 and 20 mg) will be tested in patients with treatment resistant schizophrenia. The primary endpoint is change from baseline to study week 10 in Positive and Negative Syndrome Scale (PANSS) total score. Additional endpoints include Clinical Global Impression — Severity of Illness (CGI-S) score and Personal and Social Performance Scale (PSP).
The first study is planned to enroll approximately 1,000 patients in approximately 15 countries including the U.S. and Canada and is expected to last around three years.
Lu AF35700 has been granted Fast Track designation in treatment resistant schizophrenia by FDA.