To the surprise of the global Alzheimer’s research community, China approved Shanghai Green Valley Pharmaceuticals’ algae-based Alzheimer’s treatment GV-971 last November.
When GV-971 (sodium oligomannurarate) was approved, Alzheimer’s Research UK’s director of research Carol Routledge said that there was a need for “more evidence that this drug is safe and effective”.
“For any potential drug to gain a stamp of approval by regulators in the UK, we’ll need to see larger trials in countries around the world to back up the evidence from China,” she added.
This sentiment was echoed around the world, with many praising the prioritisation of new Alzheimer’s treatments but maintaining that effective evidence was needed to support additional approvals in other countries.
It seems that Green Valley listened to the worldwide Alzheimer’s research community, and has now announced that GV-971 is set to be tested in 200 clinical centres across North America, the European Union, Eastern Europe, Asia Pacific and additional locations.
It plans to complete these global clinical trials in 2024, and will then go on to submit the drug to the FDA in the US and the European Medicines Agency in 2025.
GV-971 became the first new drug to be approved for Alzheimer’s since memantine, which was approved in Europe in 2002 and the US in 2003.
Results from clinical studies of Green Valley’s drug demonstrated that patients with mild-to-moderate Alzheimers who received a twice daily oral dose of GV-971 over 36 weeks showed a statistically-significant improvement over placebo on the ADAS-Cog 12 scales used to test cognitive function.
The mean difference between GV-971 versus placebo in ADAS-Cog12 score at the end of the study was 2.54. A three-point decline on the scale is viewed as a clinically significant worsening of Alzheimer’s symptoms.
The drug is derived from marine algae, and is said to work by inhibiting beta amyloid fibril formation, and reducing hyperphosphorylation of tau protein. It is also said to decrease inflammation in the peripheral and central nervous system and restore the natural balance of microorganisms in the gut.
If Green Valley can prove the efficacy in further testing of GV-971, it could represent a significant step forward in the treatment of a disease that has mystified researchers for years.
Biogen also surprised Alzheimer’s experts around the world when it revived its experimental therapy aducanumab for Alzheimer’s disease, after previously abandoning the drug in phase 3. It has filed the drug for approval with the FDA.
There has been much debate as to whether the FDA will approve the drug, which has controversial efficacy data, but with little treatment options for the disease, regulators may be more likely to lend aducanumab an approval.