Chinese drugmaker Shanghai Green Valley Pharmaceutical is set to begin trials for its innovative treatment for Alzheimer's in the U.S. The tests are part of its 4 billion yuan (US$600 million) global phase three trials aimed at finally releasing an effective treatment for the seemingly incurable disease.
The U.S. Food and Drug Administration gave the company's U.S. arm the green light to being tests to find out the efficacy of its treatment. The tests are meant to determine whether the drug can produce lasting cognitive improvements in patients suffering from early and late-stage Alzheimer's.
Shanghai Green Valley said that it has already identified its first patient after conducting a throughout screening process. The launch of the trials is a major step for the company and its unique treatment. Unlike other treatments, Shanghai Green Valley's drug is based on compounds extracted from brown algae.
Chinese regulators approved the use of the drug November a year ago. It became the first approved new Alzheimer's treatment in over 17 years. The debilitating neurodegenerative disorder is estimated to be present in over 5.8 million people in the U.S. and nearly 12 million people in China.
Shanghai Green Valley plans to sign up for 2,046 test subjects for its trials across the U.S., Europe and China. It expects to identify at least 600 subjects over the next six months. Within the next four weeks, it hopes to be administering doses of the drug to candidates.
"We have all seen the terrible failures worldwide as we've tried to figure out Alzheimer's disease, and we really are hoping we can be a part of something that may bring some success not only to research but some treatment to our patients," Clarity Clinical Research, the company helping Green Valley screen patients, had said in a statement.
Given the lack of any effective treatment against the disease, industry experts believe that a viable dug could open up a lucrative new market that may be worth more than $30 billion in the U.S. alone. Pharmaceutical companies from around the world have been racing to develop such a drug, spending billions of dollars over the past few years. Currently, more than 190 experimental drugs have been developers but none have proven to be effective in reversing the disorder.