Manufacturing Alliance Created for Pediatric Multiple Sclerosis Drug

Nutra Pharma Corporation recently announced a novel manufacturing alliance with Omnia Biologics to create a multiple sclerosis drug for upcoming clinical trials.

Nutra Pharma, a biotechnology company focused on pain management, is also creating novel treatments for multiple sclerosis (MS), HIV, adrenomyeloneuropathy, and pain. Omnia Biologics has a specialized approach to manufacturing processes, which will be useful for the development of the new biologic MS drug.

This alliance will allow the cloning and production of alpha-cobratoxin for the production of RPI-78M for upcoming clinical trials of pediatric multiple sclerosis, according to Nutra Pharma. RPI-78M, a drug derived from cobra venom, is an antagonist of the nicotinic acetylcholine receptor, which may be compromised in some autoimmune disorders.

The drug recently received Orphan Designation from the FDA for the treatment of pediatric multiple sclerosis. Nutra Pharma reports the treatment has a large therapeutic window, while also showing low toxicity.

Omnia Biologics will be responsible for cloning the alpha-cobratoxin gene for the raw material of the drug, according to the press release. Previous studies have shown that neurotoxins can protect nerve cell death, showing promise for the use of RPI-78M in certain neuromuscular disorders.

Omnia Biologics will also be manufacturing the drug for clinical trials, and provide process and assay development services down the line.

“Pediatric multiple sclerosis is a pressing and unmet medical need. While it is distinct from the adult form of the disease, there are no drugs approved for the treatment of Pediatric MS. These children have no other option than to rely on off label use of adult MS drugs to control their disease,” said Rik J Deitsch, chief executive Officer of Nutra Pharma. “Based on our pre-clinical and open-label studies, we believe that RPI-78M has the ability to successfully navigate the approval process. We are now working with Omnia to scale up drug manufacturing in preparation for the upcoming clinical trials.”