Up­dat­ed: Verve plans first in-hu­man base edit­ing tri­al in the US af­ter FDA lifts clin­i­cal hold

Verve Ther­a­peu­tics is plan­ning to be­gin an in-hu­man base edit­ing tri­al in the US in pa­tients with het­erozy­gous fa­mil­ial hy­per­c­ho­les­terolemia (HeFH) af­ter the FDA lift­ed a clin­i­cal hold on the com­pa­ny’s IND ap­pli­ca­tion.

Verve an­nounced Mon­day that it can now ex­pand its Phase Ib clin­i­cal tri­al in­to the US. The reg­u­la­tor had placed a hold on the IND for VERVE-101 in No­vem­ber of last year, with asks for ad­di­tion­al pre­clin­i­cal and clin­i­cal da­ta.

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