By Rob Curran
Solid Biosciences received the Food and Drug Administration's fast-track designation for a gene therapy intended to treat a condition known as Friedreich's ataxia.
Solid Biosciences will move the SGT-212 therapy into a Phase 1b early-stage clinical trial for patients with Friedreich's ataxia, a genetic condition that causes difficulties with balance, among other nervous-system symptoms. Dosing with the therapy, which comprises delivery of a frataxin gene in two different ways, will begin in the second half of the year, the company said.
Fast-track status will allow Solid Biosciences to have more frequent meetings with the FDA throughout the treatment-development process and, potentially, get the product to patients faster than would have otherwise been possible. The FDA uses it for the treatment of serious conditions or unmet medical needs.
Shares of Solid Biosciences slipped 1.8% premarket.
Write to Rob Curran at rob.curran@dowjones.com
(END) Dow Jones Newswires
January 21, 2025 09:07 ET (14:07 GMT)
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