By Simon Spichak, MSc | May 20, 2022
This Alzheimer’s drug has already been approved for use in China. Clinical trials that could lead to approval in the United States have just been abruptly canceled halfway through.
Green Valley’s international Phase 3 trial for its seaweed-derived Alzheimer’s disease drug, GV-971, was unexpectedly canceled mid-stream due to financial difficulties, according to the sites. clinical tests.
The international phase 3 study of Green Valley Pharmaceuticals’ seaweed-based Alzheimer’s disease drug has been abruptly stopped. According to several clinical trial sites, the cancellation is due to financial issues imposed by the COVID-19 pandemic as well as supply chain issues.
The drug — oligomannate or GV-971 — was approved under conditions in China in 2019. Eric Reiman, former scientific advisor to Green Valley and executive director of Banner Alzheimer’s Institute told Being Patient that he was “extremely disappointed to learn that the trial has been halted,” adding that it was terminated “due to unexpected financial difficulties related to the COVID-19 pandemic in China.”
The study, which began in October 2020, is expected to recruit 2,046 people with mild to moderate Alzheimer’s disease from 154 clinical trial centers in 10 different countries and regions. At that time, the company estimated it could complete the trial and work toward submitting an application to the Food and Drug Administration for approval by 2025.
“It was a disappointment for our team when this trial ended,” said Jeff Pohlig, CEO of Charter Research, an Alzheimer’s-focused drug trial center in Florida that was testing GV-971. He added that because the drug has shown promise in its Phase 3 clinical trial in China, he hopes Green Valley will restart and continue the study in the future.
Not everyone was impressed with the data from the first trials. Some experts have expressed skepticism about the drug’s approach, its early efficacy and safety data, and the drug company itself, following a 2008 dispute in which Green Valley encountered regulatory issues in bringing a drug to market mushroom treatment for cancer without sufficient evidence, resulting in lawsuits and bad press in China.
But given the drug’s unique target — and the deep need for effective treatments for Alzheimer’s disease — many aren’t ready to write off the “seaweed drug.”
“Speaking as someone who is no longer affiliated with Green Valley but has a keen interest in the development of [Alzheimer’s] treatments,” Reiman said, “I would still be interested in seeing the drug put to the test in a rigorous global trial.
What is oligomannate and how does it work?
the green valley seaweed medicine is the first microbiome-based therapy developed for Alzheimer’s disease. Oligomannate is extracted from a mixture of seaweed and kelp, providing food for the community of bacteria living in the gut.
By targeting gut microbes, the drug is thought to be able to treat cognitive impairment by reducing inflammation in the body and brain. This is like introducing more native flowers for pollinators into a forest; this one small change can make the ecosystem a little healthier.
The approach is in line with growing research showing that treatments for Alzheimer’s disease and cognitive impairment may come from the gut: studies have shown that altering the bacteria living in the gut can impact cognitionand, according to mouse studies, even potentially reverse some cognitive aging.
Oligomannate was the first approved under conditions in China in 2019, pending continued safety testing. In 2020, Green Valley received approval from the Food and Drug Administration to test it in the United States. Phase 3 trial conducted in Chinathe drug slowed cognitive impairment compared to a placebo control group.
Are the results convincing?
To some, the approach seemed promising even though the company has seen scandals in its past. But when it came to early results from efficacy and safety trials, the data was so Encouragingly, it has begun to attract attention – and a certain amount of skepticism – from Alzheimer’s drug experts.
Dr Lon Schneider, a professor at the Keck School of Medicine at the University of Southern California, noted that the rate of adverse effects was “remarkably” low. Schneider commented on the study for AlzForum:
“Patients in this study were not allowed to take cholinesterase inhibitorsand as has been shown in US samples, differences in clinical characteristics and course between those taking cholinesterase inhibitors and those not taking them may affect the results.
Others noted that Chinese approval of the drug came as a surprise to many scientists.
Yi Rao, a neurobiologist and president of Capital Medical University in Beijing, published reviews in Cell search question the underlying mechanism based on previous studies of the drug. In the article, he writes: “I have never come across a single drug with so many targets for curing or alleviating a disease.
Rao responded to Being Patient’s request for comment via email, saying, “It was widely suspected that GV-971 was a fraud.”
What future for oligomannate?
Green Valley has not released an official statement explaining the discontinuation of Phase 3 clinical trials.
Given the preliminary results and safety profile, Reiman hopes the drug will have another chance in clinical trials. When asked if it’s normal for companies to run out of funding during an ongoing clinical trial, Reiman said “it’s extremely rare and unexpected.”
As of this writing, Green Valley has not responded to an email request for comment.
“My heart goes out to the research participants and their families, the trial site staff and others involved in the study,” Reiman said. “Alzheimer’s disease has a terrible impact on our patients and their families, and we need to find better ways to meet their needs.