KOL Views: Did Chinese approval herald arrival of entirely new field in Alzheimer's drug R&D?

Shanghai Green Valley Pharmaceuticals announced its oligomannate (formerly known as GV-971) was approved in China to treat mild-to-moderate Alzheimer's disease (AD) "and improving cognitive function," becoming the first new medicine approved anywhere for the neurodegenerative disorder in 16 years and the first ever to target the gut microbiota. (See ViewPoints: Winds of change in Alzheimer’s blowing from the Far East?)

To provide FirstWord readers with rapid feedback on oligomannate, the strength of the evidence upon which is what approved and what it means for the future of AD research, we are hosting an expert call with a key opinion leader (KOL) on Wednesday.

Key topics that will be discussed during the call include, among other things… how familiar are you with oligomannate; how significant of a breakthrough is this Chinese approval; how firmly established is the connection between gut microbiota and neurodegenerative diseases like AD; what are the biggest question marks about the therapeutic modality; how robust is the clinical evidence available to support oligomannate, which included data from a 36-week Phase III trial conducted in China; how much buy-in from drug developers (and even acadaemia) in the US and Europe has there been into the concept of targeting the gut microbiota to treat AD; how much is this news event likely to change that; will it take successful results from a pivotal study of oligomannate that Green Valley plans to begin early next year in the US and Europe before drug developers in those regions really start ramping up their investment in the idea; how confident are you that oligomannate will prove successful and be approved in the US and Europe; how excited are you about targeting the gut microbiota as a new avenue for AD drug development; what is your opinion of the 'amyloid hypothesis'; and do you see get microbiota-targeted therapies as complementing or replacing agents focused on targets like beta amyloid and/or tau?

Ask the expert!

Furthermore, we invite FirstWord Pharma readers to submit their own questions for consideration. Please click here to do so. We can't guarantee that all questions submitted will be asked due to time constraints, but we will do our utmost to cover the important issues relating to oligomannate and the future of AD drug development.

We endeavour to provide feedback from KOLs as quickly as possible. Interview content will be published for FirstWord Pharma PLUS subscribers to read. To be notified when the interview content is available please click here.

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As always, FirstWord would very much like to receive your feedback and suggestions.

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