How RPI-78M works
MS symptoms are caused by the immune system mistakenly attacking the myelin sheath, a protective layer surrounding nerve fibers. This causes inflammation in the brain and spinal cord resulting in disrupted nerve signaling and nerve damage.
RPI-78M is a neurotoxin, derived from the venom of the Thailand cobra and made safe by chemical detoxification. It contains anticholinergic peptides, which can interact with and block the action of a receptor called nicotinic acetylcholine receptor (nAChR). nAChRs are found in the peripheral and central nervous system and are involved in regulating nerve signaling in response to the neurotransmitter (a substance used to pass messages between cells), acetylcholine. nAChRs also are found on some immune cells and could be involved in the regulation of inflammation.
RPI-78M may be beneficial for patients with neuromuscular disorders such as MS, myasthenia gravis, muscular dystrophy, and amyotrophic lateral sclerosis (ALS) where the activity of nAChRs has been compromised.
Earlier investigations of the RPI-78M in humans and animals did not show serious side effects and revealed RPI-78M to be a very stable molecule. It can be given by mouth, which eliminates the need for injections. Additionally, the therapy can be used in a large range of doses with low toxicity, eliminating the risk of overdose.
RPI-78M in clinical trials
RPI-78M was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) to treat MS in children on Sept. 8, 2015. Orphan drug status is granted to therapies that may not be lucrative to pharmaceutical companies, but are highly beneficial for people with rare diseases.
The company has completed Phase 1 clinical trials for RPI-78M, but these results have not been published. The company states that the treatment was well-tolerated and aims to move the potential drug to Phase 2 clinical trials soon.
In September 2016, Nutra Pharma announced a partnership with Omnia Biologics to prepare for the upcoming clinical trials. Omnia Biologics will clone and purify the alpha-cobratoxin gene required to produce RPI-78M. Nutra Pharma has announced a similar collaboration on May 31, 2017, with the University of Maryland’s Bioprocess Scale-up Facility (BSF), which will aim to optimize the sustainable production of RPI-78M at high quality, using the cloned gene.