Contributed by David Sultzer, MD, Professor of Psychiatry & Human Behavior
This past weekend, China’s regulatory agency conditionally approved sodium oligomannate for the treatment of mild to moderate Alzheimer’s disease. The approval was based on results from a 9-month treatment study of 818 people, and is the first approval globally of an Alzheimer’s drug in 16 years.
Oligomannate (GV-971) is a plant-based complex sugar derived from ocean seaweed. It’s thought to adjust the microbiome in the GI tract, thereby tweaking amino acid levels in the body and reducing the toxic effects of brain inflammation that contribute to Alzheimer’s disease. Results from the study haven’t been published, but the sponsor states that cognitive benefit of the drug appeared after 4 weeks of treatment and was sustained for the full 9 months of the trial. The magnitude of benefit was not large, roughly equivalent to that of cholinesterase inhibitor drugs such as donepezil, and there was no clear benefit on some other ratings. No significant side effects were noted.
Important questions remain. Whether the drug’s benefit is generalizable to other populations needs to be considered. And more information on the clinical significance of rating scale improvement, adverse effects, mechanisms involved, and effects on disease progression are needed. The sponsor plans to initiate a global study in 2020, so more to come.
But these early findings are important – they suggest benefit for those who have substantial memory deficits and other symptoms of Alzheimer’s disease, in contrast to recent Alzheimer trials focusing on those with no symptoms or very mild symptoms. They also highlight the potential value of treatment targets beyond amyloid protein, or combo mechanism approaches.
This approval follows the report last month of possible benefit from aducanumab, an anti-amyloid antibody, in a Phase 3 trial in those with mild cognitive difficulties and evidence of amyloid plaque in the brain. This drug, too, has a way to go before popping the champagne. But these two trials indicate that the needle may be moving on Alzheimer treatments and prevention. There’s still work ahead, but positive preliminary signals in two large Phase 3 trials is notable progress and a refreshing turn.
Dr. Sultzer is a Professor of Psychiatry & Human Behavior at UCI School of Medicine and leads UCI MIND’s clinical research operations, including clinical trials for new treatments. He is internationally recognized for his research activities to better understand the phenomenology, pathophysiology, and treatment of Alzheimer’s disease.