2.2 PIMAVANSERIN GÇô ADP

Pimavanserin – Alzheimer’s Disease Psychosis


Innovation

Pimavanserin is a proprietary small molecule that we have advanced to Phase II development for Alzheimer’s disease psychosis. Pimavanserin is a selective serotonin inverse agonist (SSIA) preferentially targeting 5-HT2A receptors that play an important role in psychosis.

About Alzheimer’s Disease Psychosis (AD Psychosis)

According to the Alzheimer’s Association, an estimated 5.4 million people in the United States have Alzheimer’s disease. It is currently the fifth leading cause of death for people age 65 and older. While diagnostic criteria for Alzheimer’s disease mostly focus on the related cognitive deficits, it is often the behavioral and psychiatric symptoms that are most troublesome for caregivers and lead to poor quality of life for patients. These symptoms include psychosis, agitation, and aggressive behaviors. Studies have suggested that approximately 25 to 50 percent of Alzheimer’s disease patients may develop psychosis, commonly consisting of hallucinations and delusions. The psychosis in Alzheimer’s patients is associated with even more rapid cognitive and functional decline and increased institutionalization relative to Alzheimer’s patients without psychosis. Currently, no drug is approved to treat AD Psychosis in the U.S.

Status

We announced positive top-line results from our Phase II study of pimavanserin for AD Psychosis in December 2016. Pimavanserin met the primary endpoint showing a statistically significant reduction in psychosis versus placebo as measured by the Neuropsychiatric Inventory-Nursing Home (NPI-NH) Psychosis score at week 6 of dosing (p=0.0451). Pimavanserin was generally well tolerated and the safety profile was consistent with what has been observed in previous studies. For additional information, please see the press release in the investor section of this website.