- Applied Genetic Technologies Corporation AGTC has announced additional data from the ongoing X-linked retinitis pigmentosa (XLRP) gene therapy Phase 1/2 trial, including 12-month data from Groups 5 & 6 and 24-month data from two of three Group 4 patients.
- Groups 5 and 6 had a 50% response rate among patients who met the inclusion criteria for the Skyline and Vista trials.
- Consistent with previously reported 6-month data from Groups 2, 4, 5, and 6, assessment of Best Corrected Visual Acuity (BCVA) in these groups at 12 months continues to provide supportive evidence of improved visual acuity.
- The difference between treated and untreated eyes is statistically significant.
- Data from a subset of Group 4 patients available for analysis at 24 months also provides preliminary evidence of continued durable responses and demonstrates a favorable safety profile. Two patients are still responders at Month 24.
- According to the company, this is the first XLRP gene therapy clinical trial to demonstrate continued durability of response at this time point.
- Data from all 28 patients across six dose groups continue to demonstrate a favorable safety profile with no dose-limiting inflammatory responses observed.
- This safety profile, which has shown no clinically significant inflammation not manageable with steroids, continues to be observed out to 24 months.
- The company expects to present 12-month trial results from the ongoing Phase 1/2 clinical trial at the American Academy of Ophthalmology Annual Meeting in November 2021.
- AGTC will host a conference call and webcast today at 8:00 am ET
- Price Action: AGTC shares are up 5.96% at $4.09 during the premarket session on the last check Thursday.
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