ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders, today announced that the U.S. Food and Drug Administration has completed its review of ACADIA's Investigational New Drug application to begin Phase I clinical studies with AM-831, an innovative small molecule for the treatment of schizophrenia. AM-831 was discovered by ACADIA and is being developed in collaboration with Meiji Seika Pharma Co., Ltd. The parties plan to proceed with a Phase I study to assess the safety, tolerability and pharmacokinetics of AM-831 in healthy volunteers and to help inform the design of future studies in patients with schizophrenia.
“This important progress reinforces our mutual belief in the potential of a drug with the novel profile of AM-831 and our commitment to improve the lives of patients suffering from schizophrenia.”
"We are pleased to enter clinical development with AM-831 in collaboration with ACADIA," said Yasushi Murai, Ph.D., Senior Vice President, Research and Development of Meiji Seika Pharma. "This important progress reinforces our mutual belief in the potential of a drug with the novel profile of AM-831 and our commitment to improve the lives of patients suffering from schizophrenia."
"We are excited to initiate clinical studies with AM-831," said Uli Hacksell, Ph.D., Chief Executive Officer of ACADIA. "Our preclinical studies have shown that AM-831 has the potential to be the first antipsychotic drug to combine pro-cognitive and antipsychotic effects in patients with schizophrenia, thereby addressing an area of major unmet medical need."
AM-831 is a novel and orally available small molecule that combines muscarinic m1 partial agonism with both dopamine D2 and serotonin 5-HT2A antagonism. AM-831 has demonstrated a unique combination of robust antipsychotic effects in traditional preclinical models of psychosis and pro-cognitive effects in preclinical behavioral models. In contrast, currently prescribed treatments do not effectively address or may exacerbate cognitive dysfunction associated with schizophrenia.
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