Based on FDA feedback, Applied Genetic Technologies (NASDAQ:AGTC) has revised the development plan for its gene therapy for X-linked retinitis pigmentosa, an inherited disorder affecting the retina that leads to vision loss.<\/p>\n
Enrollment in the current 30-subject Phase 1\/2 trial will be expanded. About 20 patients will be dosed, beginning in Q4, in two masked arms to collect additional functional data, including a mobility test added as a supplemental endpoint.<\/p>\n
The agency indicated that a change in visual sensitivity of at least 7 decibels in at least 5 loci would be considered clinically meaningful. The company previously reported visual sensitivity as a mean over an entire treated area. Multiple participants in the Phase 1\/2 study would meet the new criteria.<\/p>\n
The planned Phase 2\/3 trial will include two masked active arms in addition to a control arm. The primary endpoint will be visual sensitivity. Supplemental endpoints will include the mobility test. The study should launch in Q1 2021.<\/p>\n
The company will provide additional information in its 10-K filing for fiscal 2020.<\/p>\n
Shares up6%premarket on light volume.<\/p>\n
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Applied Genetic Tech to expand study of gene therapy for vision loss disorder - Seeking Alpha<\/a><\/p>\n","protected":false},"excerpt":{"rendered":" Based on FDA feedback, Applied Genetic Technologies (NASDAQ:AGTC) has revised the development plan for its gene therapy for X-linked retinitis pigmentosa, an inherited disorder affecting the retina that leads to vision loss. Enrollment in the current 30-subject Phase 1\/2 trial will be expanded Continue reading