SAN DIEGO, CA, USA I December 20, 2016 I ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) today announced positive top-line results from its Phase II exploratory study (-019 Study) of pimavanserin in patients with Alzheimer’s disease psychosis (AD Psychosis). As a selective serotonin inverse agonist (SSIA) preferentially targeting 5-HT2A receptors, pimavanserin has a different biological mechanism than other marketed antipsychotics. Pimavanserin has been approved by the United States Food and Drug Administration (FDA) for hallucinations and delusions associated with Parkinson’s disease psychosis and currently is being studied in several other disease states, including AD Psychosis. The FDA has not approved any drug to treat AD Psychosis.
In this Phase II exploratory study, 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.
“Alzheimer’s disease patients suffer from a number of debilitating symptoms, of which psychosis carries a poor prognosis and is associated with earlier placement into nursing homes,” said Steve Davis, ACADIA’s President and Chief Executive Officer. “Data from the -019 Study provide solid evidence that pimavanserin can improve psychosis in another major neurological disorder and provide strategic momentum for the further development of pimavanserin to address the needs of AD Psychosis patients.”
About the Phase II -019 Study
The Phase II -019 Study was a double-blind, placebo-controlled exploratory trial designed to evaluate the efficacy and safety of pimavanserin as a treatment for patients with AD Psychosis. A total of 181 patients were enrolled in the study in the United Kingdom and randomized on a one-to-one basis to receive either 34 mg of pimavanserin or placebo once daily. The primary endpoint of the study was antipsychotic efficacy as measured by the mean change in the NPI-NH Psychosis score (combined hallucinations and delusions domains) from baseline to week 6 of dosing. Patients continued dosing through week 12 to gather information on secondary endpoints, including changes in cognition.
Pimavanserin demonstrated efficacy on the primary endpoint of the -019 Study with a 3.76 point improvement in psychosis at week 6 compared to a 1.93 point improvement for placebo, representing a statistically significant treatment improvement in the NPI-NH Psychosis score (p=0.0451). Baseline mean scores for the pimavanserin and placebo treated groups were 9.52 and 10.00, respectively.
Atypical antipsychotics have been associated with a statistically significant worsening of cognitive function in patients with Alzheimer’s disease. In the -019 Study, over the course of 12 weeks of treatment, pimavanserin did not impair cognition as measured by the Mini-Mental State Examination (MMSE) score and was similar to placebo. On the secondary endpoint of mean change in NPI-NH Psychosis score at week 12, pimavanserin maintained the improvement on psychosis observed at the week 6 primary endpoint, but did not statistically separate from placebo.
In the -019 Study, pimavanserin was generally well tolerated and the safety profile was consistent with what has been observed in previous studies. Based on a preliminary analysis of safety data, the most common adverse events reported were falls, urinary tract infection and agitation. The mortality rate was the same in the pimavanserin and placebo treatment groups. The mean age of patients in the study was 86 years.
The data analysis of the Phase II -019 Study is ongoing and ACADIA plans to present data from this study at a future medical conference.
Conference Call and Webcast Information
ACADIA will host a conference call and webcast today, December 20, 2016 at 8:30 a.m. Eastern Time to discuss top-line results from its Phase II trial with pimavanserin in patients with Alzheimer’s disease psychosis. The conference call can be accessed by dialing 844-821-1109 for participants in the U.S. and Canada and 830-865-2550 for international callers (reference passcode 43052480). The conference call will be webcast live on ACADIA’s website, www.acadia-pharm.com, under the investors section and will be archived there until January 3, 2017. A telephone replay also may be accessed through January 3, 2017 by dialing 855-859-2056 for participants in the U.S. and Canada and 404-537-3406 for international callers (reference passcode 43052480).
About Alzheimer’s Disease Psychosis (AD Psychosis)
According to the Alzheimer’s Association, around 5.4 million people in the United States are living with Alzheimer’s disease and approximately half are diagnosed with the disease. Studies suggest that 25 to 50 percent of patients diagnosed with Alzheimer’s disease may develop psychosis, commonly consisting of hallucinations and delusions. AD Psychosis is associated with more rapid cognitive and functional decline, greater caregiver burden, and earlier institutionalization. The FDA has not approved any drug to treat AD Psychosis.
About Pimavanserin
Pimavanserin is a selective serotonin inverse agonist (SSIA) preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in AD Psychosis. Pimavanserin is being evaluated in an extensive clinical development program by ACADIA across multiple other indications including Alzheimer’s disease agitation, schizophrenia – inadequate response, schizophrenia – negative symptoms, and major depressive disorder. Pimavanserin (34 mg) was approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis by the FDA in April 2016 under the trade name NUPLAZID®. NUPLAZID is not approved for patients with AD Psychosis.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA maintains a website at www.acadia-pharm.com to which we regularly post copies of our press releases as well as additional information and through which interested parties can subscribe to receive e-mail alerts.
SOURCE: Acadia Pharmaceuticals
