Neuvivo, a biopharmaceutical company dedicated to delivering an effective, safe ALS treatment to patients, 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.”