LogicBio Says FDA Lifts Clinical Hold On LB-001 IND

(RTTNews) - Genetic medicines company LogicBio Therapeutics, Inc. (LOGC) announced Monday that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the company's LB-001 Investigational New Drug Application (IND), allowing patient enrollment to resume in the Phase 1/2 SUNRISE trial for pediatric patients with methylmalonic acidemia.

In its letter, the FDA acknowledged that the company satisfactorily addressed all clinical hold issues. The company has initiated activities to resume dosing as soon as possible.

As previously disclosed, the FDA placed the IND for LB-001 on clinical hold following the occurrence of two serious adverse events, categorized as cases of thrombotic microangiopathy (TMA), in the company's SUNRISE trial. Both cases of TMA resolved within weeks.

In connection with the lifting of the clinical hold, LogicBio amended the SUNRISE protocol in a manner that reflected its dialogue with the FDA. LogicBio expects to proceed with dosing after it implements the changes to the SUNRISE protocol, which include enhanced monitoring measures

Following the lifting of the clinical hold, the company announced that it is reinstating its previous guidance and expects to present interim clinical data from the SUNRISE trial by the end of the second quarter of 2022.