The U.S. Food and Drug Administration (FDA) has lifted the clinical hold on LogicBio Therapeutics’ (NASDAQ:LOGC) Investigational New Drug Application (IND) of its drug candidate LB-001 for pediatric patients with methylmalonic acidemia.
This regulatory action allows patient enrollment to resume in the Phase 1/2 SUNRISE investigating LB-001.
FDA indicated in its acknowledgement that LogicBio has satisfactorily addressed all clinical hold issues.
Frederic Chereau, president and chief executive officer, said, "We are pleased that the FDA has completed its review of the information we provided and that the hold on our LB-001 IND has been lifted, We look forward to dosing the next patient in our SUNRISE trial, which we expect will occur in the third quarter of 2022."
Earlier, the clinical hold was enforced by FDA following the occurrence of two serious adverse events, termed as cases of thrombotic microangiopathy (TMA). Both cases of TMA resolved within week.
As the study progressed, the company expects to present interim clinical data from the SUNRISE trial by the end of the second quarter of 2022.
LogicBio Therapeutics is trading up 54 percent at $0.77 in the pre-market session.
