PALO ALTO, Calif. , Aug. 21, 2024 /PRNewswire/ -- Neuvivo, a biopharmaceutical company developing breakthrough novel therapies for Amyotrophic Lateral Sclerosis (ALS) and other neurodegenerative diseases, today announced the appointment of Matthew William Davis , MD, RPh, as its new Chief Medical Officer.
Ari Azhir , PhD, Founder and CEO of Neuvivo, commented, "I am delighted to have Dr. Davis join our leadership team as he brings extensive experience navigating the regulatory approval process for various neurodegenerative diseases. This aligns nicely as we advance NP001 toward FDA submission.
Dr. Davis also brings exceptional experience with preparing rare disease products for commercialization. His added passion for people with ALS and the advancement of transformative treatments will be essential for leading our medical efforts as we continue to progress in our journey to make a difference.
" "The most rewarding professional experience of my career was securing FDA approval for a familial Mediterranean fever treatment, which has enabled people living with this potentially fatal disease to live a normal lifespan," said Dr. Davis. "I see the same dire need in the ALS community, and I am committed to working with Neuvivo's leadership team to advance NP001 and bring new hope to families grappling with ALS.
" Dr. Davis has spearheaded FDA approval of QWO ® , Lidoderm ® and Colcrys ® , as well as FDA clearance of Sculptra ® . For the past 20 years, he has held the titles of Chief Medical Officer, Chief Scientific Officer and Chief Operating Officer, leading R&D departments at both publicly traded, multinational biopharmaceutical companies and small, privately held startups.
Dr. Davis currently has 17 active patents listed in the FDA Orange Book. 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] SOURCE Neuvivo, Inc.
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