The ALS Association has recently awarded a $1.5 million grant to investigator Robert G. Miller, MD, to be invested in the study of a potential treatment for amyotrophic lateral sclerosis (ALS), called NP001. Dr. Miller is studying Neuraltus Pharmaceuticals’ investigational therapy which will now enter a phase 2 clinical trial.
Miller is director of the Forbes Norris MDA/ALS Research Center at Sutter Health’s California Pacific Medical Center in San Francisco and is working in collaboration with Neuraltus to develop NP001. The ALS Association grant will help fund the phase 2 clinical study, which was designed to confirm previous data on the clinical benefits of the treatment.
Inflammation is considered one of the main causes for ALS progression and NP001 is expected to decrease neuroinflammation by regulating macrophages within patients’ central nervous system. “ALS is a fatal condition with limited treatment options,” stated Dr. Miller in a press release concerning the chronic disease that affects about 400,000 people all over the world and for which there is currently no cure.
“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,” he added.
During the study, the research team led by Dr. Miller intends to evaluate the impact of NP001 on two inflammation biomarkers: interleukin-18 (IL-18) and the presence of lipopolysaccharides (LPS) in the blood. The research will enroll ALS patients who have experienced symptoms for less than three years and have a vital capacity greater than 65 percent, assessed through a breathing test.
Neuraltus plans to initiate its phase 2 study before the end of the year and announced it will disclose more details on the clinical trial by the time it begins. The study will be supported by both the $1.5 million grant from the ALS Association and roughly $1.2 million in funding raised by Neuraltus. The company and the researcher expect to improve the lives of thousands of patients suffering with the progressive and fatal neurodegenerative disease that affects motor neurons in the brain and the spinal cord.
“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 the chief scientist at The ALS Association Lucie Bruijn, PhD, MBA. “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,” added the CEO of Neuraltus Pharmaceuticals Rich Casey. “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.”