ACADIA Pharmaceuticals, a biotechnology company in San Diego, says its drug AM-831 developed with Meiji Seika Pharma Co. Ltd. in Japan to treat schizophrenia has received clearance from the Food and Drug Administration to begin phase 1 clinical trials. The clinical study will test the drug’s safety, tolerability, and interaction with the body.
AM-831 was first discovered by ACADIA and is being developed in collaboration with Meiji Seika Pharma Co. The drug, administered orally, has shown anti-psychotic effects and the ability to reduce mental confusion or disorientation in animals. Schizophrenia is a chronic, severe, and disabling brain disorder that affects about one percent of the U.S. population.
ACADIA and Meiji Seika Pharma are collaborating to develop the drug through proof-of-concept clinical studies. Meiji Seika Pharma has exclusive rights to develop and commercialize AM-831 in Asia while ACADIA retain rights to commercialize AM-831 in the rest of the world, including the U.S. and Europe. ACADIA received initial licensing fees and is eligible to receive development and regulatory milestones and royalties on product sales in Asia.
FDA completed its review of ACADIA’s Investigational New Drug (IND) application to begin phase 1 clinical studies with AM-831. The FDA reviews IND candidates to provide sponsors, such as biotechnology or drug companies, with authority to ship new drug compounds for clinical testing. For the review, the sponsor needs to show that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.
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