Seaweed-Based Drug Approved for Alzheimer's in China
— Oligomannate appears to affect gut microbiota, peripheral inflammation
A seaweed-derived oligomannate preparation (GV-971) received approval from China's National Medical Products Administration (NMPA) to treat mild to moderate Alzheimer's disease, Shanghai Green Valley Pharmaceuticals announced.
A phase III clinical trial of 818 patients with mild-to-moderate Alzheimer's disease showed that oligomannate improved cognition by week 4, showing a mean difference in ADAS-Cog 12 scores of 2.54 (P< 0.0001) between treatment and placebo arms with sustained efficacy until the end of 9 months of treatment, Green Valley said in a press release. The drug was well tolerated and adverse effects in each arm were comparable, the company added.
Full outcomes of the trial have not yet been published, but preclinical data reported in Cell Research showed that, in mice, sodium oligomannate changed gut microbiota, modulated peripheral and central inflammation, and was tied to changes in behavior and Alzheimer's-related pathology. In a commentary accompanying the preclinical study, David Holtzman, MD, of Washington University in St. Louis, and co-authors noted that "GV-971 decreases Aβ-related pathologies by reconditioning the gut microbiota, providing further evidence that gut-targeted interventions may serve as novel strategies to tackle Alzheimer's disease."
The mechanistic relationship between the microbiome and Alzheimer's remains unclear. Increasingly, researchers are looking at ways other organs may affect brain changes: altered liver enzymes have been linked to Alzheimer's disease and people who have had their appendix removed were shown to have a nearly 20% lower risk of Parkinson's disease.
The NMPA's decision marks the first novel drug approved globally for Alzheimer's disease since 2003, Green Valley said. The approval is conditional and will have monitoring for safety. The company plans a multinational phase III trial next year in the U.S, Europe, and Asia to support regulatory filings in other countries.
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