Seaweed-based Therapy Approved in China for Mild to Moderate Alzheimer’s, 1st New Treatment in 16 Years

Seaweed-based Therapy Approved in China for Mild to Moderate Alzheimer’s, 1st New Treatment in 16 Years
Oligomannate (GV-971), a compound derived from marine brown algae that promotes a healthy gut microbiome, is now conditionally approved in China to treat mild to moderate Alzheimer’s disease (AD), making it the first new disease therapy approved anywhere since Allergan’s Namenda (memantine) in late 2003. The decision was based on results from a 36-week Phase 3 trial, where treatment with oral Oligomannate was found to improve cognitive function in mild to moderate AD patients compared to placebo, and with sustained benefits. A similar pivotal trial is planned for next year in the U.S., Europe and elsewhere. Conditional approval means that the therapy's marketing will be strictly monitored, and could be withdrawn if safety issues arise. Chinese regulators also requested further research to validate the therapy’s mechanism and long-term safety and effectiveness. "There are only few drugs available to treat Alzheimer's disease, and none can delay or prevent progression of the disease," Xiao Shifu, a principal investigator for the clinical trial, said in a press release. "The results of the Phase 3 clinical study showed rapid onset of efficacy of oligomannate within 4 weeks, and that patients' cognitive function continued to improve," said Shifu, adding that safety was also evident throughout the study. Oligomannate, developed by Shangai-based
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