The company today announced that the U.S. Food and Drug Administration has completed its review of the company’s investigational new drug application to begin Phase 1 clinical studies with its AM-831 product. AM-831 is an innovative small molecule for the treatment of schizophrenia. It was discovered by ACADIA and is being developed in collaboration with Meiji Seika Pharma Company Limited, a Japanese pharmaceutical company.
Meiji Seika Pharma has exclusive rights to develop and commercialize AM-831 in the Asian region while ACADIA retains rights to AM-831 in the rest of the world. ACADIA received initial licensing fees and is eligible to receive development and regulatory milestones and royalties on product sales in the Asian territory. Meiji Seika Pharma is responsible for all costs in the Asian region and is also funding the initial development expenses of AM-831 up to a specified level. The two parties will share the remaining expenses.
AM-831 is an orally available small molecule that combines muscarinic m1 partial agonism with both dopamine D2 and serotonin 5-HT2A antagonism. The molecule has demonstrated a unique combination of robust anti-psychotic effects in traditional preclinical models of psychosis and pre-cognitive effects in preclinical behavioral models. In contrast, currently prescribed treatments do not effectively address or may even exacerbate cognitive dysfunction associated with schizophrenia.
For more information about ACADIA Pharmaceuticals and AM-831, please visit the company’s website at www.acadia-pharm.com
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