PALO ALTO, Calif.--(BUSINESS WIRE)--Neuvivo, Inc., a late-stage biopharmaceutical company developing treatments for neurodegenerative disease, today announced it has gained alignment with the U.S. Food and Drug Administration (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.
Throughout his distinguished career, Dr. Curnutte has held senior leadership roles, including as Head of Research and Development at Portola Pharmaceuticals, where he played a key role in the development and approval of multiple therapies. He currently serves on the boards of Pliant Therapeutics and Cayuga Biotech (and recently on the Orchard Therapeutics Board before its acquisition by Kyowa Kirin), contributing to companies at the forefront of scientific innovation. He also serves as an advisor to Samsara BioCapital and Astra Zeneca.
Neuvivo commits to updating its website at Neuvivo.com as more information on the Phase 3 study is available. Patients with ALS who wish to be considered for enrollment in the study should e-mail trial@neuvivo.com. Sites that wish to be qualified for the study should email sites@neuvivo.com.
About NP001
NP001 is an investigational therapy that could become the first immunotherapy for ALS designed to restore balance within a dysfunctional innate immune system where pro- and anti-inflammatory processes are no longer in equilibrium. NP001 has been granted Orphan Drug and Fast Track Designations by the US Food and Drug Administration. For more information, please visit www.Neuvivo.com or www.clinicaltrials.gov (NCT03179501, NCT01091142, and NCT02794857)
About Neuvivo Inc.
Neuvivo is a private, late-clinical stage biopharmaceutical company dedicated to creating and delivering advanced treatments for ALS and other neurodegenerative diseases. Neuvivo has developed a proprietary immunotherapy platform that includes a patented formulation for NP001 and its manufacture. For more information, please visit www.Neuvivo.com.
References:
- Andrews JA, Meng L, Kulke SF, et al. Association Between Decline in Slow Vital Capacity and Respiratory Insufficiency, Use of Assisted Ventilation, Tracheostomy, or Death in Patients With Amyotrophic Lateral Sclerosis. JAMA Neurol. Jan 1 2018;75(1):58-64. doi:10.1001/jamaneurol.2017.3339
- Guidance for Industry: Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment. September 2019. (2019).
- Miller RG, Zhang R, Block G, et al. NP001 regulation of macrophage activation markers in ALS: a phase I clinical and biomarker study. Amyotroph Lateral Scler Frontotemporal Degener. Dec 2014;15(7-8):601-9. doi:10.3109/21678421.2014.951940
- Miller RG, Zhang R, Bracci PM, et al. Phase 2B randomized controlled trial of NP001 in amyotrophic lateral sclerosis: Pre-specified and post hoc analyses. Muscle Nerve. Jul 2022;66(1):39-49. doi:10.1002/mus.27511
- McGrath MS, Zhang R, Bracci PM, Azhir A, Forrest BD. Systemic Innate Immune System Restoration as a Therapeutic Approach for Neurodegenerative Disease: Effects of NP001 on Amyotrophic Lateral Sclerosis (ALS) Progression. Biomedicines. Oct 16 2024;12(10)doi:10.3390/biomedicines12102362
- Forrest BD, Goyal NA, Fleming TR, et al. The Effectiveness of NP001 on the Long-Term Survival of Patients with Amyotrophic Lateral Sclerosis. Biomedicines. Oct 16 2024;12(10)doi:10.3390/biomedicines12102367
Contacts
Media: media@neuvivo.com
General Inquiry: info@neuvivo.com
