A Chinese drug “Oligomannate” to treat Alzheimer’s is scheduled to begin clinical trials across Europe and the US next year to gain global legitimacy as a viable treatment for the disease.
By James DiGeorgia
Shanghai Green Valley Pharmaceutical Co. is planning to recruit over 2046 patients suffering from mild or moderate cases for Alzheimer’s for taking part in their trials in over 200 sites spread throughout Asia Pacific, Europe, and North America for eighteen months, stated Li Jinhe, the company’s VP on Sunday.
Named Oligomannate, this drug received conditional approval from Chinese regulatory agencies in November. It has been available since December 29 in China. Patients are required to take three capsules two times daily, as per the instructions provided on the package. One week’s worth of drugs would cost around $128 or 895 yuan.
Green Valley announced these plans at a conference held in Beijing, nearly two months after it made global headlines for being approved by China’s drug regulator for coming out with the 1st innovative Alzheimer’s medication in over 17 years. Global drug manufacturers haven’t yet been able to come up with a viable solution for the neurodegenerative disease even though over 190 experimental medications have been launched in the last few decades, seeking to combat the disease.
Many experts are questioning whether Green Valley, which is practically unknown outside China, has found a viable treatment for the disease. Treating the disease is something that has baffled Western pharma companies for decades.
Lyu Songtao, Chairman of Green Valley, stated that they were confident about the drug’s success as the results from their clinical trials had been positive so far.
The approval also requires the company to conduct additional studies documenting the workings of the drug along with efficacy and safety in the long run. The firm has stated that it is planning to pour over $3B into new studies for the next ten years to explore its working mechanisms and expand its usage for treating diseases like vascular dementia and Parkinson’s.
China’s drug regulatory agency has been approving experimental novel treatments at a rapid pace compared to its European and American counterparts as it races to provide top-notch healthcare to its citizens. Beijing is currently developing its biotech industry for enabling Chinese domination in scientific and medical research.
Over 5.8M and 10M people in the United States and China have Alzheimer’s. Researchers estimate that there are over 50M people around the world who have dementia, with over 70% of them suffering from Alzheimer’s as well. This means that Green Valley could earn huge profits if it were able to receive approval from global agencies. The US alone is estimated to have a $30B market for a drug that could halt Alzheimer’s, as per an estimate from Sanford C. Bernstein & Co.
While giants like Roche Holding AG, AstraZeneca PLC, and Eli Lilly & Co have all poured billions over the last few decades for finding a viable treatment, they have all failed. Biogen Inc. had announced plans to restart its studies into an experimental therapy in October after a new analysis displayed promising results.
The company is also planning to seek permission for clinical trials from the US FDA by February 2020. It is intending to secure the FDA’s Fast Track drug designation, which enables an expedited review of the drugs used for treating serious medical conditions or filling unmet medical needs. The firm is also looking to partner up with global drug manufacturers for launching the drug outside China and speeding up the clinical trials.
The therapy championed by Green Valley is a different take on treating Alzheimer’s compared to western drug manufacturers. Its Oligomannate drug, which is the name of a type of sugar that’s extracted from brown seaweed, doesn’t focus on beta-amyloid, which is a protein known for forming plaque clump inside the brains of patients suffering from Alzheimer's.
Although drugmakers have been facing backlash over fixating on this protein for finding a cure, pharma companies are yet to explore a different alternative. Green Valley’s drug is seeking to readjust gut microbiome, thus enabling reduced inflammation of neurons, which then slows down the disease’s progression.
This drug improved the cognitive abilities of patients diagnosed with mild and moderate forms of Alzheimer’s within 28 days, stated the company. However, other experts have been skeptical about these results since no comprehensive details have been provided about this Chinese study.
Local media sources have reported that several industry researchers are now demanding more evidence for proving that alteration of the gut microbiome is enough for slowing down cognitive impairment.