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# LogicBio Therapeutics IND Clinical Hold
- URL: https://www.fdaweb.com/logicbio-therapeutics-ind-clinical-hold/
- Published: 2020-02-11T12:00:00.000Z
- Updated: 2026-09-14T16:02:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146060

FDA has placed a clinical hold on a LogicBio Therapeutics IND for LB-001 for treating methylmalonic acidemia (MMA) pending resolution of certain clinical and nonclinical questions. The company [says](ttps://investor.logicbio.com/news-releases/news-release-details/logicbio-therapeutics-provides-update-fda-review-investigational) it submitted the IND 1/2020 to support the initiation of a Phase 1/2 clinical trial in patients with MMA. It says it will work closely with the agency to resolve the questions as quickly as possible.

LB-001 is described as an investigational pediatric genome editing therapy based on the company’s GeneRide technology. It is said to enable site-specific integration and lifelong expression of therapeutic transgenes without the use of exogenous promoters or nucleases. It is designed to incorporate a functioning version of the faulty human methylmalonyl-COA mutase gene into the genome of MMA patients.