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UH Medical School: Phase 1b study announced of NP001 in patients with mild-to-moderate Alzheimer’s Disease

Date: September 13th, 2017 in Research    Print or PDF

Pictured: The University of Hawaiʻi Clinics at Kakaʻako

SAN BRUNO, Calif. and HONOLULU, Sept. 13, 2017 — A clinical trial will begin soon on a drug that researchers hope will reduce inflammation in patients with Alzheimer’s Disease.

The University of Hawai’i (UH) John A. Burns School of Medicine (JABSOM) will recruit 14 people, seven of whom will be randomly assigned to obtain the medicine, and seven who will be given a placebo, in what is referred to as a “Phase 1b” clinical trial. The trial involves an investigational therapy, NP001, developed by Neuraltus Pharmaceuticals, Inc., a privately held biopharmaceutical company dedicated to developing innovative therapeutics for neurodegenerative diseases. This study (NCT03179501) aims to whether a single dose of NP001 will affect blood markers that indicate inflammation in individuals with mild-to-moderate Alzheimer’s disease.

The patients selected for the study will receive NP001 or the placebo intravenously at the UH Clinics at Kakaʻako on the JABSOM campus. Researchers and nurses from the R-MATRIX (Multidisciplinary And Translational Research Infrastructure Expansion) Program will oversee the trial.

To sign up for the trial, call: Debbie – (808) 692-1332 or Lorna – (808) 692-1333.

“This trial wouldn’t be happening in Hawaiʻi without the RMATRIX (Multidisciplinary And Translational Research Infrastructure Expansion) Program at JABSOM, which supports the mentoring of junior scientists and the professional relationships forged through scientific collaboration,” said Dr. Cecilia Shikuma, Professor of Medicine, who oversees operations at the UH Clinics at Kakaʻako.

“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, UHM-JABSOM, 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 University of Hawaiʻi medical school 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,” said Rich Casey, Neuraltus Pharmaceutals CEO.

Pictured is Dr. Beau Nakamoto

Dr. Beau Nakamoto will oversee the trial.

More About the Phase 1b Study of NP001
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. Further information about the study is available at https://clinicaltrials.gov.

About Alzheimer’s Disease
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.

About the John A. Burns School of Medicine at the University of Hawaiʻi at Mānoa
The John A. Burns School of Medicine (JABSOM) at the University of Hawaiʻi Mānoa honors its unique research environment to excel in scientific-based efforts to eliminate diseases that disproportionately affect people in Hawaiʻi and the Pacific region. Annually at JABSOM, more than 500 future physicians are learning medicine, JABSOM researchers secure up to $52 million in grants, and overall economic stimulus to Hawaiʻi from the school tops $456 million annually. JABSOM also confers degrees in Clinical Translational Research, Communication Sciences and Disorders, Tropical Medicine, Cell and Molecular Biology, Medical Technology and Developmental and Reproductive Biology. http://jabsom.hawaii.edu.

About Neuraltus Pharmaceuticals, Inc.
Neuraltus Pharmaceuticals, Inc. is a privately-held biopharmaceutical company dedicated to developing and commercializing innovative therapeutics that address critical unmet needs for patients and physicians in the treatment of neurodegenerative diseases. NP001, the Company’s lead product candidate, is also being studied in patients with amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s disease).

For more information, please visit www.neuraltus.com.

National Institutes of Health. (2017, July 28). Alzheimer’s Disease Fact Sheet. Retrieved August 01, 2017, from https://www.nia.nih.gov/health/alzheimers-disease-fact-sheet.

Contact: Edie DeVine, GCI Health
Office: +1 (209) 814-9564

SOURCE Neuraltus Pharmaceuticals, Inc.
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