ACADIA Meets Primary Endpoint Alzheimer's Disease Exploratory Study; Stock Rallys

Shares of ACADIA Pharmaceuticals Inc. ACAD gained more than 15 percent early Tuesday morning after the company announced positive top-line results from a Phase II study (-019 Study) of its therapy to treat Alzheimer's Disease called pimavanserin.

Acadia's therapy has a different biological mechanism than other marketed antipsychotics and has already been approved by the U.S. Food and Drug Administration (FDA) for the treatment of hallucinations and delusions associated with Parkinson's.

Acadia is also studying pimavanserin as a treatment for other disease states, including AD Psychosis, for which there are no currently FDA approved drug.

Phase II Results

Acadia said its Phase II exploratory study involving pimavanserin met the primary endpoint and showed 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).

The Phase II study was a double-blind, placebo-controlled exploratory trial designed to evaluate the efficacy and safety of pimavanserin. The study consisted of 181 patients in the United Kingdom.

Acadia further noted:

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.