China's Oligomannate, a seaweed-based drug for Alzheimer's treatment, received approval for clinical trials in the United States and Europe in 2020. The makers of the drug were inspired by the remarkably lower occurrence of Alzheimer's among elderly people who eat seaweed regularly.
Oligomannate is made from Shanghai Green Valley Pharmaceutical Co, which is now recruiting about 2,046 Alzheimer's patients to participate in the global test runs. Trials are set to take place in 200 laboratories situated across North America, Europe, and the Asia Pacific.
So far, Green Valley estimates that the trials could last for the next 18 months. After, the pharmaceuticals are filing an application for clinical trials with the US Food and Drug Administration in February. It hopes to secure approval for Fast Track designation.
The team hopes for the global clinical trials and further investigations to be completed by 2024. By 2025, the company hopes Oligomannate could register as a drug.
The clinical trials proceeded under conditional approval given by the Chinese government. Under the conditions, Green Valley will further investigations on how the drug affects patients in the long-term. To investigate, Green Valley said it would allocate $3 billion in the next 10 years. Investigations will include if Oligomannate can treat Parkinson's and vascular dementia.
Jeffrey Cummings, founding director of the Cleveland Clinic Lou Ruvo Center for Brain Health in the US, will lead the clinical trials. Cummings also serves as an adviser to Green Valley.
Observers from the global medical sector are having mixed reactions about Oligomannate's speedy approval for clinical trials. The reactions stemmed from the fact that there have been many western pharmaceuticals forced to abandon their development of Alzheimer's treatment because of ailed attempts.
For instance, big pharmaceuticals such as AstraZeneca PLC, Eli Lily & Co, and Roche Holding AG, spent billions for their respective developments but to no avail. Compared to these giants, Green Valley is a relatively unknown entity.
Meanwhile, as the world awaits the results of clinical trials, China had already approved Oligomannate to be sold within the country. The Alzheimer's treatment went on sales starting December 29 across the country.
Oligomannate comes in 150mg capsules. As of present, it costs a patient $512 to be on the medication for a month. Green Valley, however, hopes prices could be lowered as wide acceptance happen. Or, at least Oligomannate could be included in the list of subsidized medicines of the local government.
There were about 9,5 million people in China who are suffering from Alzheimer's disease as of 2015. Worldwide, there are 46 million affected by the condition. Experts said the numbers are expected to balloon every 20 years.
