ACADIA Pharmaceuticals Announces Positive Top-Line Results From Phase II Study of Pimavanserin for Alzheimer's Disease Psychosis
2016-12-20 07:00:00 AM ET (BusinessWire)
--Conference Call and Webcast to Be Held Today, December 20, 2016, at 8:30 a.m. Eastern Time
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.
