FDA Lifts Solid Bio Clinical Hold, Duchenne Study Cleared to Resume

Solid Biosciences has answered the FDA’s outstanding questions about its Duchenne muscular gene therapy, clearing a clinical trial to now resume after patient complications last year led the agency to halt the study for a second time.

Cambridge, MA-based Solid Bio (NASDAQ: SLDB) said Thursday that it expects dosing of patients in the Phase 1/2 study testing its experimental gene therapy, SGT-001, will start again in the first quarter of 2021. When it does, the maximum weight of patients in the study will be lowered, a change intended to boost safety. The therapy is dosed according to a patient’s weight.... Read more »


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Author: Frank Vinluan

Source : https://xconomy.com/boston/2020/10/01/fda-lifts-solid-bio-clinical-hold-duchenne-study-cleared-to-resume/


Date : 2020-10-01T16:42:47.000Z

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