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Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced non-human primate (NHP) long-term safety data of ADVM-022, an intravitreally delivered gene therapy currently in phase 1 for the treatment of wet age-related macular degeneration (wet AMD).
Data was presented by David M. Brown, M.D., Clinical Professor of Ophthalmology at Baylor College of Medicine, vice-chair for research at the Blanton Eye Institute, Houston Methodist Hospital, and partner at Retina Consultants of Houston, at the 2019 Angiogenesis, Exudation, and Degeneration Conference in Miami, FL on February 9, 2019 in the session titled “Gene Therapy for Neovascular AMD: Intravitreal Delivery of AAV-7m8 vectors”.
“I am encouraged by the growing body of evidence from a wide range of non-human primate data that continues to support the durability and safety of ADVM-022 gene therapy and the potential to treat patients with wet AMD with a single intravitreal injection,” said David M. Brown, M.D. “ADVM-022 utilizes the current standard of care delivery method that patients are familiar with in my practice and has the potential to greatly improve their quality of life by decreasing the treatment burden.”
“We are excited to share interim data from a preclinical study which show that the normal non-human primate retinal structure is maintained 21 months after a single intravitreal injection of 2×10^12 vg of ADVM-022, as measured by optical coherent tomography. These preclinical results are very encouraging in terms of ocular safety of long-term, robust expression of the anti-VEGF molecule, aflibercept,” said Mehdi Gasmi, Ph.D., president and chief scientific officer of Adverum Biotechnologies. “With the initiation of our phase 1 OPTIC study in November last year, we look forward to bringing this unique therapeutic candidate closer to treating patients living with wet AMD.”
- Long-term expression of aflibercept in the retina from ADVM-022 does not affect retinal morphology as evaluated by optical coherence tomography (OCT) at 21 months post ADVM-022 injection
- Complete data set including functional endpoints (electroretinography) and ocular tissue histology to be presented at additional upcoming conferences