Verve re­veals let­ter from FDA that lays out con­di­tions to lift base edit­ing tri­al hold

We now know why Verve’s lead can­di­date was placed on hold last month by US reg­u­la­tors.

In an SEC fil­ing, Verve laid out the FDA’s con­di­tions for lift­ing the hold on its lead ther­a­py, VERVE-101. That in­cludes sub­mit­ting pre­clin­i­cal da­ta about po­ten­cy dif­fer­ences in hu­man ver­sus non-hu­man cells, risks of gene edit­ing germline cells, and off-tar­get analy­ses in non-he­pa­to­cyte cell types.

The FDA al­so wants clin­i­cal da­ta from the on­go­ing Heart-1 tri­al, and to mod­i­fy the tri­al pro­to­col in the US to add ad­di­tion­al con­tra­cep­tive mea­sures and in­crease the length of a stag­ger­ing in­ter­val be­tween the dos­ing of par­tic­i­pants.

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