Neuvivo Seeks FDA Approval for ALS Treatment NP001

Neuvivo, a biopharmaceutical company focused on advanced clinical stages, has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for NP001, a sodium chlorite infusion intended to treat amyotrophic lateral sclerosis (ALS). This investigational treatment aims to be the first disease-modifying therapy for ALS, addressing the disease through an immunologic mechanism rather than a neurologic one. If approved, NP001 could significantly impact the treatment landscape for ALS by restoring balance in the body's innate immune system and managing uncontrolled inflammation.

ALS, a progressive neurodegenerative disease, gradually impairs a person's muscle function, affecting their ability to walk, talk, eat, and breathe. The current life expectancy for someone diagnosed with ALS is between 2-5 years, primarily due to respiratory failure. Presently, no treatments are available that can extend life expectancy or preserve breathing function by more than a few months. Approximately 30,000 adults in the U.S. live with ALS, and 1 in 300 people will be diagnosed with this debilitating disease over their lifetime.

Dr. Ari Azhir, Founder and CEO of Neuvivo, emphasized the company's dedication to developing new treatments to enhance the quality of life for ALS patients. He expressed optimism about NP001's potential to preserve lung function and extend survival by up to a year, especially for patients with biomarkers indicating uncontrolled inflammation due to ALS. Dr. Matthew W Davis, Chief Medical Officer of Neuvivo, supported this optimism, noting the positive evidence from Phase 2a, Phase 2b, and Overall Survival studies, along with biomarker analysis, as strong support for the NDA submission.

Dr. Namita Goyal, a Clinical Professor of Neurology at the University of California, Irvine, and a Neuromuscular Medicine specialist, highlighted the hope that NP001's potential FDA approval brings to ALS patients, their families, and caregivers. She acknowledged the importance of collaboration with the investigative team and Neuvivo's persistent efforts to reach this significant milestone.

NP001 is designed as a transformative therapy to restore balance within a dysfunctional innate immune system, where the equilibrium between pro- and anti-inflammatory processes is disrupted. By achieving this balance, NP001 aims to slow ALS progression and preserve skeletal muscle function, including that of the diaphragm. If approved, it would be the first treatment of its kind, potentially providing a meaningful effect on patients' lives by preserving lung function, a feat that no other therapy has achieved so far.

The FDA has granted NP001 Orphan Drug and Fast Track Designations, making it eligible for Accelerated Approval and Priority Review, which could expedite the approval process. Neuvivo filed the NDA for NP001 in October 2024. Previous studies have shown that NP001 is generally safe and well tolerated.

Neuvivo is a private, late-clinical stage biopharmaceutical company dedicated to developing and delivering advanced treatments for ALS and other neurodegenerative diseases. The company's proprietary platform includes a patented formulation for NP001 and its manufacturing process, positioning it at the forefront of innovative ALS treatment development.