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AGTC Provides Trial Design Update for its Phase 2/3 XLRP Clinical Trial, New Data on XLRP Higher Dose Group and Financial Results for the Fourth Quarter and Year Ended June 30, 2020
- Planned Phase 2/3 trial expected to include approximately 60 patients and a responder analysis based on at least 7 decibel improvement in visual sensitivity in at least 5 loci across two active dose groups and one control group -
- Data from Group 5 supports use of higher dose level in Phase 2/3 trial -
- Company on track to provide multiple data readouts for XLRP and ACHM clinical programs in 4Q 2020 -
- Company to host management update and webcast with slides today at 8:00am ET -
GAINESVILLE, Fla., and CAMBRIDGE, Mass., September 9, 2020 Applied Genetic Technologies Corporation (Nasdaq: AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, today provided additional information about the proposed design of the planned Phase 2/3 trial for its X-linked retinitis pigmentosa (XLRP) clinical program, which is expected to commence in the first quarter of 2021, and new preliminary data on a higher dose Group 5 from the ongoing Phase 1/2 XLRP trial. The Company also announced financial results for the fourth quarter and fiscal year ended June 30, 2020.
We are excited to close out our 2020 fiscal year with a path toward initiating a Phase 2/3 trial for our XLRP program, and to provide new preliminary data for the higher dose Group 5 in our Phase 1/2 trial, which supports inclusion of that dose level in the Phase 2/3. In addition, we remain on track to report additional data readouts from all three of our clinical programs in the fourth quarter of the 2020 calendar year, said Sue Washer, President and CEO of AGTC. The advancements we are making in our clinical programs, highlighted by the proposed design of our planned Phase 2/3 XLRP trial, underscore our continued progress.
The following information was filed by Applied Genetic Technologies Corp (AGTC) on Wednesday, September 9, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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