Acadia Pharmaceuticals is to begin a Phase I clinical study of AM-831, an innovative small molecule for the treatment of schizophrenia, in collaboration with Meiji Seika Pharma.
AM-831 combines muscarinic m1 partial agonism with both dopamine D2 and serotonin 5-HT2A antagonism.
The US Food and Drug Administration has reviewed the company's investigational new drug application to advance the clinical development with AM-831.
The Phase I study is intended to evaluate the safety, tolerability and pharmacokinetics of the drug candidate in healthy volunteers and to help inform the design of future studies in patients with schizophrenia.
Acadia Pharmaceuticals CEO Uli Hacksell said that pre-clinical studies showed AM-831 to be the first antipsychotic drug to integrate both pro-cognitive and antipsychotic effects in schizophrenia patients.