Clinical-Grade Product Expected Before End of Year
Palo Alto, CA, May 11, 2022 – Neuvivo, a biopharmaceutical company dedicated to delivering an effective, safe ALS treatment to patients, today announced that it has initiated cGMP manufacturing of NP001 for the treatment of ALS (Lou Gehrig’s Disease). The company expects to have product available by the end of the year for clinical use.
NP001 has received FDA’s Fast Track and Orphan Drug designation. It has been shown to be effective and safe in clinical trials. Published data show a 38% slowing of disease progression as measured by ALSFRS-R score and importantly, a 51% slowing of the decline in lung function compared to placebo. There have been no serious adverse events reported in clinical trials.
Neuvivo is partnering with Patheon, ThermoFisher’s industry leading API contract development and manufacturing organization (CDMO). Manufacturing will be performed at Patheon’s facility in Florence, South Carolina, a site acquired from Roche Holdings.
“We spent the past months evaluating manufacturing options and are pleased to announce our drug development partnership with ThermoFisher to produce NP001 for clinical use,” said Ari Azhir, PhD, Founder and CEO, Neuvivo. “We anticipate having quantities of drug available by the end of the year and possibly sooner. All at Neuvivo recognize the nature of this terrible disease and the need to make more effective treatments available as soon as possible.”
About Neuvivo: Neuvivo is a private, late-clinical stage biopharmaceutical company focused on developing 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.
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 equilibrium to the immune system.
Data on NP001 clinical trials published in peer-reviewed Muscle&Nerve Feb 1, 2022 - show a 38% slowing of disease progression as measured by ALSFRS-R score and critically, a 51% slowing of decline of lung function, a key measure of survival. For more information please visit: www.Neuvivo.com
About ThermoFisher: Thermo Fisher Scientific has won six awards in the 11th annual CMO Leadership Awards. The awards, presented by Life Science Leader and Outsourced Pharma, recognize top contract manufacturing partners as evaluated by biopharma and biotech companies. Thermo Fisher won across all six categories, including: Capabilities, Compatibility, Expertise, Quality, Reliability and Service. This is the third consecutive year Thermo Fisher has received this recognition across all six categories and ninth time overall that the company has been honored by the CMO Leadership Awards
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. “Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD”. For more information, please visit www.thermofisher.com