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Neuraltus, University of Hawaii Initiate Phase 1b NP001 Study for Mild-to-Moderate Alzheimer's

September 14, 2017 By americanpharmaceuticacreview

Neuraltus Pharmaceuticals and the John A. Burns School of Medicine, University of Hawaii at Manoa announced the initiation of a Phase 1b placebo-controlled biomarker study of the company's investigational therapy, NP001, in individuals with Alzheimer's disease. This study (NCT03179501) is being conducted to determine the effect of a single dose of NP001 on blood markers of inflammation in individuals with mild-to-moderate Alzheimer's disease.

"Although Alzheimer's disease is the most common cause of dementia, there is presently no cure for the more than five million Americans living with the disease," said Beau Nakamoto, MD, PhD, MBA Associate Professor, Department of Medicine, University of Hawaii at Manoa, John A. Burns School of Medicine, and principal investigator. "Given the key role inflammatory monocytes and macrophages may play in the progression of Alzheimer's disease, researching immune regulators - like NP001 - is critical to understanding more about this serious and complex disease."

Alzheimer's disease, an irreversible, progressive brain disorder that slowly destroys memory and thinking skills, is currently ranked as the sixth leading cause of death in the United States. While the cause of the disease is unknown, there is increasing evidence that suggests neuroinflammation may play a role in disease progression. NP001, Neuraltus Pharmaceuticals' lead investigative therapy, is designed to help regulate neuroinflammation.

"We anticipate the Phase 1b study being conducted by the John A. Burns School of Medicine will help further validate the importance of biomarker research in neurodegenerative conditions, such as Alzheimer's disease," said Rich Casey, chief executive officer, Neuraltus Pharmaceuticals. "NP001 has shown promising results in reducing systemic inflammation levels in patients with other neurodegenerative diseases, and we hope that this study will show that it works similarly in Alzheimer's disease. This is the first clinical study of NP001 in Alzheimer's disease and we look forward to examining the results to see whether the compound impacts inflammation levels in this patient population."

The Phase 1b single-site, randomized, double-blind, placebo-controlled pilot biomarker study will enroll 14 individuals with mild-to-moderate Alzheimer's disease. Patients will receive a single dose of either NP001 or placebo, both of which will be given intravenously. The study is designed to measure changes from baseline at one and seven days following dosing in inflammatory monocyte-associated biomarkers. With the support of the RCMI Multidisciplinary And Translational Research Infrastructure Expansion (RMATRIX) program (NIMHD grant number U54MD007584), the study is being conducted by researchers and nurses from the RMATRIX program using the doses of NP001 provided by Neuraltus.

Alzheimer's disease is a type of dementia that causes problems with memory, thinking and behavior. Symptoms usually develop slowly and get worse over time, becoming severe enough to interfere with daily tasks. The cause of the disease is currently unknown, but there is increasing evidence that implicates neuroinflammation with the progression of the disease. It is believed that in people with Alzheimer's disease, there are increased levels of inflammatory (activated) macrophages, a type of white blood cell, resulting in the release of factors in the central nervous system that damage motor neurons. NP001, a regulator of macrophage activation, exerts its effect by converting these activated inflammatory macrophages back to their normal state.

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