H. Lundbeck A/S 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.