Months lat­er, Log­icBio ex­its FDA clin­i­cal hold for gene edit­ing drug but won't restart tri­al un­til next quar­ter

Log­icBio Ther­a­peu­tics has re­ceived some good news this morn­ing as the FDA has lift­ed a three-month clin­i­cal hold on one of the com­pa­ny’s pri­ma­ry tri­als for a po­ten­tial gene edit­ing drug, but the tri­al isn’t ex­pect­ed to re­sume un­til next quar­ter.

En­roll­ment in the Phase I/II tri­al, dubbed SUN­RISE, for Log­icBio’s gene edit­ing ther­a­py LB-001 will be al­lowed to re­sume. The tri­al is fo­cused on pe­di­atric pa­tients with methyl­malonic acidemia, or MMA, an in­her­it­ed dis­or­der in which the body is un­able to process cer­tain pro­teins and lipids prop­er­ly.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER