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Zafgen, FDA reach consensus for ZGN-1061 study
September 2019
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BOSTON—Clinical-stage biopharmaceutical company Zafgen Inc. has established an agreement with the U.S. Food and Drug Administration for an in-vivo animal study design and protocol to determine relevant safety margins for ZGN-1061, Zafgen’s investigational MetAP2 inhibitor. The study will seek to translate data from Zafgen’s in-vitro assays of human endothelial cells and assessment of tissue factor expression with endothelial cells, as well as other assays, in order to resolve a clinical hold. Top-line data are expected by the end of the year.
 
Dr. Priya Singhal, Zafgen’s head of Research and Development, said in part that, “We are working to rapidly implement the in-vivo animal study, which aims to establish the relevance of the in-vitro mechanism and safety margins. We appreciate the FDA’s thorough feedback and continuing collaboration throughout this process.”

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