Neuvivo Files NDA for Lou Gehrig’s Therapy

Neuvivo has submitted an NDA for NP001 (sodium chlorite infusion) to treat amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease). The investigational treatment aims to “restore balance over uncontrolled inflammation within the body’s own innate immune system,” the company says, adding that it targets ALS from a more immunologic mechanism than neurologic. It says the therapy may substantially preserve lung function and extend overall survival by up to a year, especially in patients identified through therapeutic biomarkers as having ALS-related uncontrolled inflammation.

The company says two placebo-controlled Phase 2 ALS trials showed that NP001 administration was associated with a significantly greater retention of physical function in patients and they had significantly greater maintenance of respiratory function. NP001 was previously granted FDA orphan drug and fast track designations.