A drug derived from algae meant to improve intestinal health is entering a new phase of testing as a treatment for Parkinson’s disease, as recent research has shown a relationship between the disease and gut microbiota.
Earlier this month, Shanghai-based Green Valley Pharmaceuticals received approval from the U.S. Food and Drug Administration to proceed with phase II testing for sodium oligomannate, also known as GV-971, for treatment of people with early-stage Parkinson’s. The drug was approved in China to treat Alzheimer’s in 2019.
Green Valley calls the drug “the world’s first [Alzheimer’s] drug that targets the gut-brain axis.” The connection between gut microbiota – the general term for bacteria and other microbes that make up the microbiome in the human digestive tract – and neurodegenerative diseases has gotten a lot of attention in recent years.
According to Parkinson’s News Today, inflammation in the colon can lead to misfolding of proteins in that part of the body. Plaque from these misfolding, or malfunctioning, proteins in the brain is a hallmark of neurodegenerative diseases such as Parkinson’s. The link between the gut and the brain is still unclear, but studies show a correlation between gut inflammation and diseases like Parkinson’s and Alzheimer’s.
According to Green Valley’s announcement, the company’s preclinical research shows GV-971 “is able to regulate gut microbiota dysbiosis, suppress α-synuclein aggregation in both the gut and the brain, reduce neuroinflammation, protect dopaminergic neurons, and improve motor and non-motor symptoms.”
GV-971 has yet to be approved for use in the U.S., and will have more testing to go through even if phase II trials go well. The testing will only involve individuals with early-stage Parkinson’s.
The phase III testing process for the oral drug specifically for the treatment of Alzheimer’s has begun in the United States and several other countries. This testing is expected to be complete by 2025.
For the phase II Parkinson’s trials, Green Valley plans to work with about 300 patients in both North America and Asia. The trials will last 36 weeks, but a start date has yet to be announced.
According to the Journal of Neural Transmission in 2017, approximately 1% of people over 60 years old have Parkinson’s disease. The second-most common neurodegenerative disease after Alzheimer’s, Parkinson’s affects nearly 6 million Americans, according to the Centers for Disease Control.