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AGTC files investigational new drug application for gene therapy product
Applied Genetic Technologies Corp. has filed an investigational new drug application with the FDA to conduct a phase 1/2 clinical trial of its gene therapy product candidate for treating achromatopsia, according to a company press release.
The adeno-associated virus-based gene therapy is under consideration as treatment for achromatopsia caused by mutations in the CNGB3 gene. A multicenter clinical study in the U.S. is planned to evaluate safety and efficacy of the gene therapy product, according to the press release
“In addition to finalizing our collaboration agreement with Biogen, initiating our phase 1/2 clinical trial for XLRS, and expanding our product pipeline, we remain on track to have a second product candidate in clinic shortly, pending the FDA’s acceptance of the IND application and approval from the sites’ institutional review boards,” AGTC president and CEO Sue Washer said in the release.
In July, Biogen and AGTC entered into a collaboration and licensing agreement to develop gene-based therapies for ophthalmic diseases.