Neuvivo

Neuvivo is a late-clinical stage biopharmaceutical company based in Palo Alto, California, established in 2020 to develop treatments for neurodegenerative diseases, with a primary focus on Amyotrophic Lateral Sclerosis (ALS). The company was founded by a team of experienced industry professionals, including CEO Ari Azhir, PhD, and Chief Scientific Officer Michael McGrath, MD, PhD. Dr. Azhir has a background in biophysics and has founded other biopharmaceutical companies, while Dr. McGrath is an Emeritus Professor of Medicine at UCSF, where the initial discoveries leading to Neuvivo's lead candidate were made.

The company's core focus is on its lead drug candidate, NP001, a sodium chlorite infusion. The business model centers on the development and future commercialization of this therapeutic. Neuvivo operates in the biopharmaceutical market, a sector characterized by high research and development costs, stringent regulatory oversight, and the potential for significant returns upon successful drug approval and market entry. The company has raised capital through venture funding, including an $11M round in June 2023, to finance its clinical trials and regulatory submission processes.

NP001 represents a distinct approach to treating ALS by targeting the body's innate immune system rather than pursuing a purely neurologic mechanism. The therapy is designed to modulate macrophage activity, aiming to restore balance over uncontrolled inflammation, which is considered a critical factor in the progression of ALS. Evidence suggests that neuroinflammation contributes to the destruction of motor neurons; NP001 is designed to regulate this process, potentially slowing the decline in lung function and extending survival for patients. The drug candidate was previously developed by Neuraltus Pharmaceuticals, which ceased operations after Phase 2b trials did not meet their primary endpoints. Neuvivo acquired the asset and, using post-hoc analysis of the previous studies which suggested benefits for a subset of patients with high inflammation, has advanced the treatment.

A significant milestone was achieved in October 2024, when Neuvivo submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for NP001. This submission is supported by data from Phase 2a and 2b clinical trials and subsequent survival studies. The FDA has previously granted NP001 both Orphan Drug and Fast Track designations, which could potentially expedite the review process. If approved, NP001 would be a first-in-class therapy addressing the immunologic aspects of ALS, serving patients who currently have limited treatment options that offer only modest extensions in survival.

Keywords: Neuvivo, biopharmaceutical, ALS treatment, NP001, neurodegenerative disease, sodium chlorite infusion, immunotherapy, macrophage modulation, late-clinical stage, FDA New Drug Application, Ari Azhir, Michael McGrath, neuroinflammation, Orphan Drug designation, Fast Track designation, motor neuron disease, amyotrophic lateral sclerosis, clinical trials, venture capital-backed, immunologic therapy, respiratory function, life sciences