LogicBio Therapeutics (NASDAQ:LOGC) has submitted an Investigational New Drug (IND) application with the FDA to initiate a Phase 1/2 trial of LB-001, a recombinant adeno-associated viral vector with human methylmalonyl-COA mutase gene for the treatment of methylmalonic acidemia (MMA).
Additional details regarding the trial size, endpoints, and timelines will be disclosed once the FDA accepts the IND. The Company plans to initiate a Phase 1/2 trial in pediatric MMA patients in H1 2020, with preliminary data expected in H2.
LogicBio also highlighted key recent and upcoming milestones:
Initiated Retrospective Natural History Study in MMA. This study is designed to evaluate disease progression in pediatric patients with severe MMA.
Reported positive data on Next Generation Capsid Development program at European Society of Gene and Cell Therapy Annual Meeting.
Doubling available lab and office space to support GeneRide platform development and capabilities expansion. LogicBio expects to move into new headquarters in Lexington, Mass. in the spring of 2020.
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