Shanghai Green Valley Pharmaceuticals (China) has announced that the country’s regulatory agency has approved oligomannate (GV-971) as a new drug for the treatment of mild-to-moderate Alzheimer’s disease. This decision marks the first new drug approval for Alzheimer’s disease since 2003.
Oligomannate, which is an orally administered drug made from extracts of brown algae, is reported to:
- Recondition dysbiosis of gut microbiota;
- Inhibit the abnormal increase of intestinal flora metabolites;
- Modulate peripheral and central inflammation;
- Reduce amyloid protein deposition and tau hyperphosphorylation;
- Improve cognitive function.
Speaking about the study findings, Carol Routledge, who is Director of Research at Alzheimer’s Research UK (Cambridge, UK), commented: “While it might sound strange for a potential Alzheimer’s drug to come from seaweed, many naturally occurring compounds provide the basis for developing medicines.”
“Research suggests that this drug may work by affecting the activity of bacteria in the gut and there is growing evidence of an important link between the gut and the brain,” Routledge added.
Within the Phase III clinical trial results for oligomannate, a total of 818 participants with mild-to-moderate Alzheimer’s disease were included and completed the study. The results demonstrated that oligomannate statistically improved cognitive function in individuals with mild-to-moderate Alzheimer’s disease as early as week 4. Additionally, it was reported that the benefit of the drug was sustained at each follow-up assessment.
The mean difference between oligomannate and placebo groups in ADAS-Cog12 score was 2.54 (p < 0.0001), with sustained efficacy from first month of treatment to the end of 9 months of treatment. Oligomannate was also reported to be safe and well tolerated with side effects that were comparable to the placebo arm.
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“I have been doing research on Alzheimer’s disease for 50 years, participated in multiple global multicenter studies of multiple drugs, and have never found a satisfactory treatment for Alzheimer’s disease,” commented Zhang Zhenxin, a leading principal investigator of the oligomannate study. “The result of the 9-month trial of oligomannate is exciting. We finally see hope and dawn. I am sincerely happy for the patients and their families.”
The drug is expected to be available in China by the end of 2019. Following the launch of oligomannate in China, the company will also plan to submit marketing authorization applications in selected countries. A multicenter global Phase III clinical trial (GREEN MEMORY) with sites in the USA, Europe and Asia is planned to be initiated in early 2020 to support global regulatory filing of oligomannate.
“We must await full data from this study and further clinical trials before we can fully assess the potential of oligomannate to improve the lives of people with Alzheimer’s disease,” stated Routledge.
Sources: www.prnewswire.com/news-releases/green-valley-announces-nmpa-approval-of-oligomannate-for-mild-to-moderate-alzheimers-disease-300950349.html; www.alzheimersresearchuk.org/new-drug-for-mild-and-moderate-alzheimers-approved-in-china/