PALO ALTO, Calif. , Aug. 22, 2024 /PRNewswire/ -- Neuvivo, a biopharmaceutical company developing breakthrough novel therapies for Amyotrophic Lateral Sclerosis (ALS) and other neurodegenerative diseases, today announced the appointment of Mark Henderson , PhD, as the company's new Vice President of Manufacturing.
In this role, Dr. Henderson will oversee manufacturing, quality assurance and drug formulation, including for NP001 — Neuvivo's investigational treatment for ALS — which has been granted Orphan Drug and Fast Track Designations by the FDA. "Dr.
Henderson's industry expertise and innovative mindset will be crucial in establishing our manufacturing processes and maintaining our rigorous quality standards," said Ari Azhir , PhD, founder and CEO of Neuvivo. "As we advance NP001, Dr. Henderson's leadership will be pivotal in our efforts to improve care for those living with ALS.
" Dr. Henderson brings over 25 years of experience in pharmaceutical facility operations, quality assurance and manufacturing. Working across both global biotechnology companies and a private, clinical-stage startup, he has held leadership roles in early-stage manufacturing and process development for well-established groups as well as building teams from the ground up.
"I've devoted my career to producing new treatments for those in need, and I'm energized by the thought of using my expertise to help bring NP001 to the ALS community," said Dr. Henderson. Dr.
Henderson has authored components of multiple regulatory filings, including multiple New Drug Applications (NDAs) (Kuvan ® and Firdapse ® ), Biologics License Applications (BLAs) (Naglazyme ® , Vimizim ® and Palynziq ® ) and marketing authorization applications (MAAs) (Aldurazyme ® , Naglazyme ® , Vimizim ® , Kuvan ® and Firdapse ® ). About ALS Amyotrophic Lateral Sclerosis (ALS) is a relentlessly progressive neurodegenerative disease without cure that, over time, takes away a person's muscle function and impacts their ability to walk, talk, eat and — ultimately — breathe. Even with available treatments, the current life expectancy of a person with ALS is about 2-5 years after symptoms appear, with death usually resulting from respiratory failure.
1 There are currently no medicines available for ALS that preserve breathing function or extend life by more than 2-3 months. Approximately 30,000 adults in the US are living with ALS, 2 and 1 in 300 people will be diagnosed in their lifetime. 3 About NP001 NP001 is a transformative, investigational therapy that could become the first innate immunotherapy for ALS designed to restore balance within a dysfunctional innate immune system where pro- and anti-inflammatory processes are no longer in equilibrium.
By regaining balance to this natural process, NP001 may help slow the progression of ALS and preserve skeletal muscle function, including the diaphragm. To date, no other therapy has been able to preserve lung function. If approved, NP001 would be the first disease-modifying treatment with this novel mechanism of action and potentially have a meaningful effect on the lives of people with ALS.
NP001 has been granted Orphan Drug and Fast Track Designations by the FDA and is eligible for Accelerated Approval and Priority Review, which could shorten the time to a potential approval. A New Drug Application (NDA) for NP001 in ALS is expected to be filed by the end of 2024. About Neuvivo 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 platform that includes a patented formulation for NP001, and its manufacture. For more information, please visit www.Neuvivo.
com . Contact Edie Elkinson [email protected] 1. Masrori P, Van Damme P .
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12688/f1000research.10476.1 SOURCE Neuvivo, Inc.
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