Casey Lynch, Cortexyme CEO

Up­dat­ed: Cor­texyme's un­ortho­dox Alzheimer's ap­proach tripped up by FDA hold

The FDA has thrown a mi­nor wrench in Cor­texyme’s un­ortho­dox plan to treat Alzheimer’s.

On Mon­day, the Bay Area biotech an­nounced that the agency had put one of the stud­ies in their piv­otal pro­gram on hold af­ter the com­pa­ny re­port­ed that pa­tients ex­pe­ri­enced liv­er prob­lems while tak­ing their lead drug. The is­sues were re­versible and had no known long-term ef­fects, the com­pa­ny said.

The hold will not af­fect the Phase II/III, blind­ed, ran­dom­ized con­trolled study they hope to read out to­wards the end of this year. In­stead, the agency has de­cid­ed to end, for the time be­ing, an open-la­bel ex­ten­sion study that had been mea­sur­ing their mol­e­cule’s long-term ef­fects on pa­tients who al­ready com­plet­ed the ini­tial 48-week study. No new pa­tients will be en­rolled and pa­tients cur­rent­ly in the tri­al will be dis­con­tin­ued.

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