AGTC to Showcase Interim Findings from Ongoing XLRP and Achromatopsia Phase 1/2 Trials at the Association for Research in Vision and Ophthalmology 2022 Annual Meeting
Applied Genetic Technologies Corporation (Nasdaq: AGTC) announced multiple presentations at the ARVO 2022 annual meeting concerning ongoing clinical trials in X-linked retinitis pigmentosa (XLRP) and achromatopsia (ACHM). Key presentations include interim safety results and findings on visual photosensitivity from Phase 1/2 trials. With a focus on gene therapy for rare inherited retinal diseases, AGTC aims to validate its technology platform. Results from these studies may support future regulatory filings, emphasizing the potential impact of AGTC’s therapies on patient care.
- Ongoing clinical trials in XLRP and ACHM demonstrating potential advancements.
- Presentations at ARVO 2022 showcasing interim results, enhancing visibility.
- Focus on unmet clinical needs in inherited retinal diseases, indicating strong market potential.
- Gene therapy remains novel with uncertainties regarding regulatory approval.
- Ongoing risks and uncertainties related to clinical trials and funding sources.
GAINESVILLE, Fla., and CAMBRIDGE, Mass., April 04, 2022 (GLOBE NEWSWIRE) -- Applied Genetic Technologies Corporation (Nasdaq: AGTC), a clinical stage biotechnology company focused on the development of adeno-associated virus (AAV)-based gene therapies for the treatment of rare and debilitating diseases with an initial focus on inherited retinal diseases, today announced multiple presentations related to the Company’s ongoing clinical trials in X-linked retinitis pigmentosa (XLRP) and achromatopsia (ACHM) at the Association for Research in Vision and Ophthalmology’s 2022 Annual Meeting (ARVO 2022), taking place May 1 – 4, 2022 in Denver, Colorado. The presentations will be available virtually on May 11 – 12, 2022.
“We are excited to share these interim results from our ongoing gene therapy trials with members of the ophthalmology community,” said Dr. Susan Schneider, Chief Medical Officer of AGTC. “Over the past year, we have continued to validate the potential of our gene therapy platform with interim results from multiple clinical trials in XLRP and ACHM. We anticipate that these findings will add to the growing body of evidence supporting our investigational treatments for those with rare inherited retinal diseases.”
AGTC presentations at ARVO 2022:
Findings on Visual Photosensitivity in Two Phase 1/2 Clinical Trials of Subretinal Gene Therapy with AGTC-401 and AGTC-402 for CNGB3 and CNGA3 ACHM (paper)
Presenter: Rachel Huckfeldt, M.D., Ph.D., Assistant Professor of Ophthalmology at Harvard Medical School
Session Date/Time: May 1, 2022; 2:45 – 4:45 p.m. MDT
Presentation Date/Time: 2:45 – 3:02 p.m. MDT
Location: Four Seasons Ballroom 1
Interim Safety Results in Two Phase 1/2 Open-label, Dose-escalation Clinical Trials of Subretinal Gene Therapy with AGTC-401 and AGTC-402 in Subjects with Achromatopsia (ACHM) (poster)
Presenter: Alessandro Iannaccone, MD, MS, Professor of Ophthalmology and Director of the Center for Retinal Degenerations and Ophthalmic Genetic Diseases at Duke University School of Medicine
Poster Session Date/Time: May 3, 2022; 1 – 3 p.m.MDT
18-Month Analysis of Macular Structure Using Optical Coherence Tomography (OCT) from a Phase 1/2 Clinical Study of Subretinal Gene Therapy Drug AGTC-501 for X-Linked Retinitis Pigmentosa (XLRP) (poster)
Presenter: Paul Yang, MD, PhD, Assistant Professor of Ophthalmology at the Casey Eye Institute, Oregon Health & Science University in Portland
Poster Session Date/Time: May 4, 2022; at 3 – 5 p.m.MDT.
About AGTC
AGTC is a clinical-stage biotechnology company developing genetic therapies for people with rare and debilitating ophthalmic, otologic and central nervous system (CNS) diseases. AGTC is a leader in designing and constructing all critical gene therapy elements and bringing them together to develop customized therapies with the potential to address unmet patient needs. AGTC’s most advanced clinical programs leverage its best-in-class technology platform to potentially improve vision for patients with inherited retinal diseases. AGTC has active clinical trials in X-linked retinitis pigmentosa (XLRP) and achromatopsia (ACHM CNGB3). Its preclinical programs build on the company’s industry leading AAV manufacturing technology and scientific expertise. AGTC is advancing multiple important pipeline candidates to address substantial unmet clinical needs in optogenetics, otology and CNS disorders, and has entered strategic collaborations with companies including Bionic Sight, an innovator in the emerging field of optogenetics, and retinal coding and Otonomy, Inc., a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. For more information, please visit https://agtc.com/.
Forward-Looking Statements
This release contains forward-looking statements that reflect AGTC's plans, estimates, assumptions and beliefs, including statements about the potential of the company’s gene therapy platform and the strength of the expected interim results from multiple clinical trials in XLRP and ACHM and whether these results will support future regulatory filings. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as "anticipates," "believes," "could," "seeks," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would" or similar expressions and the negatives of those terms. Actual results could differ materially from those discussed in the forward-looking statements, due to a number of important factors. Risks and uncertainties that may cause actual results to differ materially include, among others: gene therapy is still novel with only a few approved treatments so far; AGTC cannot predict when or if it will obtain regulatory approval to commercialize a product candidate or receive reasonable reimbursement; uncertainty inherent in clinical trials and the regulatory review process; risks and uncertainties associated with drug development and commercialization; risks and uncertainties related to funding sources for our development programs; the direct and indirect impacts of the ongoing COVID-19 pandemic on the Company’s business, results of operations, and financial condition; factors that could cause actual results to differ materially from those described in the forward-looking statements are set forth under the heading "Risk Factors" in the company’s most recent annual report on Form 10-K, as it may be supplemented by subsequent periodic reports filed with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent management's plans, estimates, assumptions and beliefs only as of the date of this release. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
PR Contact:
Kerry Sinclair
Spectrum Science Communications
ksinclair@spectrumscience.com
Corporate Contact:
Jonathan Lieber
Chief Financial Officer
Applied Genetic Technologies Corporation
T: (617) 843-5778
jlieber@agtc.com
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