San Diego, Calif.-based biopharmaceutical company ACADIA Pharmaceuticals Inc. (ACAD:NASDAQ) today announced that its Phase 3 HARMONY study evaluating pimavanserin for the treatment of dementia-related psychosis met its primary endpoint, demonstrating a highly statistically significant longer time to relapse of psychosis with pimavanserin compared to placebo in a planned interim efficacy analysis. The firm further reported that upon the recommendation of the study's independent data monitoring committee, which met to review the data from the planned interim efficacy analysis, the study will now be stopped early based on pre-specified stopping criteria requiring a one-sided p-value less than 0.0033 on the study's primary endpoint.
The company plans to meet with the U.S. Food and Drug Administration (FDA) regarding a supplemental New Drug Application (NDA) submission in 2020, and the results from the HARMONY study will be submitted for presentation at upcoming medical meetings. The FDA previously granted Breakthrough Therapy Designation for pimavanserin for the treatment of dementia-related psychosis. No drug is approved by the FDA for the treatment of dementia-related psychosis.
Jeffrey Cummings, M.D., Sc.D., Director Emeritus of Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, commented, "Psychosis adds dramatically to the marked burden that dementia patients already carry and is one of the most challenging-to-manage aspects of the disease for caregivers...With no approved treatment options available today for dementia-related psychosis, the pimavanserin study results represent a meaningful advance that will potentially bring us a much needed therapy for this debilitating disease."
ACADIA's President Serge Stankovic, M.D., M.S.P.H., stated, "We are very excited that today's results bring us one step closer to the potential of offering patients with dementia-related psychosis a critically needed treatment option...We look forward to speaking with the FDA about a supplemental new drug application (NDA) to support pimavanserin for the treatment of dementia-related psychosis. I want to thank all of the patients, their families, and the investigators for their participation in this important study."
The firm indicates that pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in psychosis, schizophrenia, depression and other neuropsychiatric disorders.
The HARMONY Study is a Phase 3 study double-blind, placebo-controlled relapse prevention trial designed to evaluate the efficacy and safety of pimavanserin for the treatment of delusions and hallucinations associated with dementia-related psychosis across a broad population of patients with the most common subtypes of dementia including: Alzheimer's disease, dementia with Lewy bodies, Parkinson's disease dementia, vascular dementia, and frontotemporal dementia spectrum disorders. The study included a 12-week open-label stabilization period during which patients with dementia-related psychosis were treated with pimavanserin 34 mg once daily. Dose reduction to 20 mg once daily was allowed if clinically justified within the first four weeks.
The company advised in the release that around 8 million people in the United States are living with dementia and studies suggest that approximately 30% of dementia patients, or 2.4 million people, have psychosis, commonly consisting of delusions and hallucinations. Serious consequences have been associated with severe or persistent psychosis in patients with dementia such as repeated hospital admissions, increased likelihood of nursing home placement, progression of dementia, and increased risk of morbidity and mortality.
ACADIA Pharmaceuticals states that its vision is to become the leading pharmaceutical company dedicated to the advancement of innovative medicines that improve the lives of patients with central nervous system (CNS) disorders. The company received FDA approval for NUPLAZID (pimavanserin) in April 2016, the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. The firm also has ongoing clinical development efforts in additional areas with significant unmet need, including dementia-related psychosis, schizophrenia, major depressive disorder, and Rett syndrome.
ACADIA shares opened much higher today at $41.79 (+$17.99, +75.59%), compared to Friday's $23.80 closing price. The stock has traded today between $36.62 and $43.98/share and at present is trading at $39.21 (+$15.41, +64.75%).[NLINSERT]
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