Intellia, Verve run clinical trials abroad amid FDA’s ‘cautious’ approach to gene editing

In­tel­lia Ther­a­peu­tics an­nounced ear­li­er this month that it would run a mid-stage tri­al of a CRISPR-based treat­ment for a rare ge­net­ic dis­ease called hered­i­tary an­gioede­ma (HAE) en­tire­ly out­side of the US. The de­ci­sion came af­ter the FDA asked for more re­search on re­pro­duc­tive ef­fects if the tri­al was to in­clude women of child-bear­ing age.

So far, at least two gene edit­ing com­pa­nies — In­tel­lia and Verve Ther­a­peu­tics — have de­cid­ed to run ear­ly- or mid-stage clin­i­cal tri­als out­side the US, as FDA takes a more cau­tious ap­proach than for­eign reg­u­la­tors to the nascent field of gene edit­ing.

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