Palo Alto, CA, Dec 16, 2021: Neuvivo, Inc., a company developing clinical-stage treatments for ALS and other neurodegenerative diseases, announced that it has submitted to the FDA a request for a Type C meeting to solicit feedback on the proposed development pathway for its lead candidate, NP001, for the treatment of ALS. The request is based on achieving statistical significance in two clinical endpoints in a modified ITT integrated analysis of two placebo-controlled Phase 2 clinical trials.
“We are looking forward to feedback from the FDA next month on the development of NP001 as a new treatment for ALS patients,” said Ari Azhir, PhD, Neuvivo founder and CEO.
NP001 is a first-in-class, disease-modifying, anti-inflammatory NCE being investigated for the treatment of neuroinflammatory conditions, such as ALS. Early patents relating to the technology are under license from the University of California, San Francisco.
“There are currently very limited treatment options for people living with ALS,” said Bruce Forrest, MD, Chief Medical Officer, Neuvivo. “There are emerging data implicating inflammation in the progression of ALS, suggesting that treatment with NP001 may offer a promising new strategy to manage this disease.”
About NP001: NP001 is a multifactorial immune system regulator. It is a first-in-class NCE with a known mechanism of action that targets diseased macrophages in the central nervous system to restore immune balance. NP001 has received FDA Fast Track and Orphan Drug designation.
About Neuvivo: Neuvivo is a private biopharmaceutical company focused on creating and delivering advanced treatments for ALS and other neurodegenerative diseases. The company was formed by successful industry leaders and scientists, committed to improving the prognosis for patients diagnosed with ALS and a range of diseases for which few current treatment options exist. For more information please visit: www.Neuvivo.com.