Neuvivo Seeks FDA Approval for Its Breakthrough ALS Treatment NP001

Neuvivo, a late-clinical stage biopharmaceutical company, today announced it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for NP001 (sodium chlorite infusion) to treat amyotrophic lateral sclerosis (ALS). NP001 is an investigational treatment that, if approved, could be the first disease-modifying therapy for ALS that restores balance over uncontrolled inflammation within the body’s own innate immune system. The NP001 treatment is unique as it targets ALS from a more immunologic mechanism than neurologic.

There are currently no medications available for ALS that preserve breathing function or extend life by more than 2-3 months. Approximately 30,000 adults in the U.S. are living with ALS and 1 in 300 people will be diagnosed in their lifetime.

“ALS is a devastating disease and patients who are fighting ALS need much better treatment options,” said Ari Azhir, PhD, Founder and CEO of Neuvivo. “Our organization was built on our passion and commitment to help those struggling with ALS by finding new treatments that can make a meaningful difference in their quality of life. We are thrilled to have submitted NP001 for FDA approval as the treatment platform may substantially preserve lung function and extend overall survival by up to a year, especially in patients identified through therapeutic biomarkers as having underlying, uncontrolled inflammation as a result of ALS.”

Matthew W Davis, MD, RPh, Chief Medical Officer of Neuvivo, added: “Based on the evidence shown across the Phase 2a, Phase 2b, and Overall Survival studies as well as the biomarker analysis, we believe submitting the New Drug Application to the FDA for NP001 offers great promise to the ALS community.”

Dr. Namita Goyal, MD, Clinical Professor of Neurology at University of California, Irvine, and Neuromuscular Medicine specialist, said: “The submission of NP001 for FDA approval brings new hope to people living with ALS, their families and caregivers. We are truly honored to have collaborated with such a distinguished investigator team and thankful for Neuvivo’s resilience with continuing to develop NP001 to reach this critical milestone.”