Neuraltus Pharmaceuticals, Inc., a privately-held biopharmaceutical company focused on the development of groundbreaking drugs to treat neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS), announced today that Robert G. Miller, M.D., Director of the Forbes Norris MDA/ALS Research Center at Sutter Health's California Pacific Medical Center in San Francisco, has been awarded a grant from The ALS Association for $1.5 million to help fund a Phase 2 clinical study of the company's investigational therapy for ALS, NP001. Inflammation is thought to be a contributing factor to ALS disease progression, and NP001 is believed to reduce neuroinflammation through the regulation of macrophage white blood cells within the central nervous system. The Phase 2 study is intended to help confirm the potential clinical benefits seen in the previous study of NP001, the results from which were published in the April 2015 issue of Neurology: Neuroimmunology & Neuroinflammation, an official journal of the American Academy of Neurology. Approximately 400,000 people worldwide are living with ALS, also known as Lou Gehrig's disease, a progressive and fatal neurodegenerative disease that affects motor neurons in the brain and the spinal cord.
"ALS is a fatal condition with limited treatment options," said Dr. Miller. "Clinical research of promising investigational drugs, like NP001, is critically important as we continue to learn more about this devastating disease. This Phase 2 study is expected to provide valuable insights, not only about NP001, but also on the role of inflammation in disease progression and the biomarkers identified by Neuraltus in a previous study."
The Phase 2 study, which is expected to begin before the end of the year, will be designed to confirm the potential impact of NP001 on two inflammation biomarkers: interleukin-18 (IL-18) and the presence of lipopolysaccharide (LPS) in the blood. The study will focus on patients who have had ALS symptoms for less than 3 years with a vital capacity (breathing test) greater than 65 percent. More specific details regarding the Phase 2 study of NP001 will be disclosed at the time of trial initiation. The $1.5 million grant, awarded by The ALS Association, will be combined with approximately $1.2 million in funding and support contributed by Neuraltus.
"The more we can learn from promising research, like that being conducted by Dr. Miller and the Neuraltus team, the more insight we have into the physiological profile of ALS," said Lucie Bruijn, Ph.D. M.B.A, Chief Scientist, The ALS Association. "Awarding grants to fund research like the Phase 2 study of NP001 is vitally important in our pursuit of possible treatment options for ALS patients."
"We appreciate the grant support from The ALS Association to help us advance the clinical development of NP001 as a potential treatment for patients with ALS," said Rich Casey, Neuraltus Pharmaceuticals' Chief Executive Officer. "We look forward to working with Dr. Miller, the ALS community and The ALS Association on this Phase 2 study as we work to advance NP001 as quickly as possible toward a pivotal clinical trial."
Neuraltus Pharmaceuticals, Inc.