Neuvivo announced it has gained alignment with the FDA on a regulatory path forward for NP001 as a unique immunotherapy to treat amyotrophic lateral sclerosis (ALS). This follows a Type C meeting, in which the company and the Neurology 1 Division of the FDA discussed the efficacy and safety requirements for acceptance, review and potential full approval of its New Drug Application (NDA). In addition, Neuvivo also announces that Dr. John Curnutte has accepted a position on its Board of Directors.
“I appreciate the collaborative meeting with the FDA. If approved, NP001 will be the first ALS treatment using Vital Capacity as the primary outcome of a double-blinded, placebo-controlled, multi-national Phase III pivotal trial,” said Ari Azhir, PhD, Founder and CEO of Neuvivo. “It is our goal to start the Phase 3 trial in 2026. I commit to keeping the ALS community updated on our progress. It is based on this exciting development that Dr. John Curnutte has agreed to join our Board of Directors and I look forward to working with him and the rest of the board to bring this important therapeutic option to ALS patients.”
Michael McGrath, MD, PhD, co-founder and Chief Scientific Officer Neuvivo and Emeritus Professor of Medicine at University of California, San Francisco, said: “Post-hoc analyses of our Phase 2 data indicate a strong correlation between NP001 treatment with preservation of vital capacity (greater than 15%) and overall survival (up to 25 months) compared to placebo. We now can use our Phase 2 data along with the published research of Dr. Jinsy Andrews in accordance with FDA ALS guidelines and feedback from the Type C meeting to design and adequately power our pivotal phase 3 study. I am equally excited to work with Dr. Curnutte on the Board. His wealth of experience will help guide Neuvivo during the next phase of clinical development of NP001”
Dr. Curnutte brings decades of scientific and executive leadership in biotechnology and drug development to Neuvivo. He has served on the boards of several innovative biotechnology companies, where his strategic insight and deep clinical expertise have helped guide programs from early development through regulatory approval.
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