LogicBio Therapeutics Announces FDA Lifts Clinical Hold on SUNRISE Trial in Pediatric Patients with Methylmalonic Acidemia
Company initiates activities to resume dosing
Interim clinical data from Phase 1/2 trial expected to be presented by end of second quarter 2022
LEXINGTON, Mass., May 9, 2022 /PRNewswire/ — LogicBioTherapeutics, Inc.(Nasdaq: LOGC), a clinical-stage company advancing a diversified pipeline of genetic medicines addressing rare disorders from infancy through adulthood, today announced 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.
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