Green Valley Pharmaceutical Company, a Shanghai based biotech startup, has cleared regulatory hurdles from China's FDA-equivalent to approve a potential Alzheimer's drug, drawn primarily from brown algae.
The drug, oligommanate, is now approved in China to treat Alzheimer’s patients and is currently entering phase three clinical trials in the United States. This is impactful, especially when considering that China holds the largest population of people living with Alzheimer’s disease.
“Over the course of 36 weeks, there was an improvement in cognition in people given the drug compared to people given the placebo,” Dr. Michelle Papka, one of the researchers in the trial, said of the trial results so far to the Global Alzheimer’s Platform Foundation.
In the United States, the Phase 3 trials – for which researchers are currently recruiting participants – are double-blind, meaning neither the researchers nor the participants know which participants are receiving the drug or the placebo. At the end of the study, however, there is a six-month guarantee that those who were given the placebo will receive the actual drug.
Several of the experimental Alzheimer's drugs currently making headlines, like Biogen’s aducanumab and the arthritis drug olumiant, target the beta-amyloid plaques that often accumulate in the brain of a person with Alzheimer's. This drug, however, takes a new approach: it hones in on the gut biome, which refers to the microbes in our intestines, and indirectly targets the brain by addressing an imbalance of microorganisms in the gut. While this could be a promising approach for Alzheimer's treatments, it makes for a tricky drug target because usually the gut biome metabolizes nutrients from food and ingredients from medication.
Oligommanate, however, is a large chain sugar extracted from brown algae that the body does not break down. In other words, it remains in the gut, working to balance the good and bad bacteria, which can lead to excess inflammation. Dr. Jeffrey Norton, a principal investigator at Charter Research (one of the clinics that is recruiting for clinical trials), says that in a way, the drug works like a strong probiotic. “It’s appealing to a lot of patients,” he said. “It gives people another option because it’s a little more naturalistic.”
It is estimated that between 70 to 80 percent of the body’s immune system is in the gut. Some scientists now even refer to the gut as our second brain. But this was not always the case. “Gut health is something that was not appreciated until very recently,” said Dr. George Perry, neurobiology professor at The University of Texas at San Antonio. “The gut plays such an important role in diseases because the gut has more cells in it than the body itself. It's also where most of the inflammatory cells are in the body. It's clear that there's a huge amount of the immune system actually residing in the gut.”
In recent years there has been mounting evidence linking chronic inflammation to Alzheimer’s disease. Inflammation does have an important purpose – it serves as the body’s defense mechanism against infection and injury and is a critical part of the immune process. However, excess, or chronic inflammation can eventually result in your body's inflammatory response to damage healthy cells, tissues, and organs.
“A lot of what we know about excess inflammation is observational, like we've seen in cardiac disease. We're sort of working backwards from there,” Dr. Norton explained. He says the belief is that excess inflammation affects microglial cells (cells that are located throughout the brain and spinal cord), which are like scavengers that are designed to clean up degenerated tissue. The current theory, he relayed, is that excess inflammation injures microglial cell’s function.
Perry says even though the link between the gut and Alzheimer's disease is more observational than concrete, the potential connection is enough to breathe new life into treating the disease. “It's really intriguing and certainly points to the microbiome being really critical for overall health. That's why this type of approach using brown algae could have value – because you're looking at controlling inflammation.”
According to Dr. Norton, the drug’s current standing, which is one phase away from FDA approval, means it has cleared all the safety hurdles that researchers usually worry about when new medications are being developed. “It’s definitely shown to have some efficacy in improving cognition in people taking the pill versus the placebo,” Dr. Norton said of the results in China and the phase two results in the United States. “It also has minimal, if any, side effects. Dealing with an older population, where they may be mixing numerous medications, that is always a concern.”
The trial has already started recruiting participants, with hopes of enrolling close to 2,000 patients who are between 50-85 years old with mild to moderate Alzheimer’s disease. There are 32 study locations across the country, allowing for more accessibility. Although the initial results are encouraging, these upcoming findings will give further, necessary insight into whether the United States will follow in China’s lead.
If you or someone you know is interested in participating in this clinical trial, call Charter Research in Lady Lake, Florida at 352-775-1000. There is no cost to participate, and insurance is not required.