Aviceda Submits Investigational New Drug Application for AVD-104 for the Treatment of GA Associated with AMD

Aviceda Therapeutics announced that it has submitted an investigational new drug (IND) application to the FDA. The IND supports the use of its lead intravitreal ocular asset, AVD-104 (a novel glycan-coated nanoparticle), for the treatment of GA secondary to AMD. Aviceda previously announced the successful completion of IND-enabling Good Laboratory Practice (GLP) toxicity studies that showed positive safety data for multiple well-tolerated doses of AVD-104. This included dose-range finding studies in non-human primates (NHPs) and rabbits (80 total animals), to support continued development and the initiation of human clinical trials.

“With only one currently approved therapy for the treatment of GA, there is still a significant unmet medical need for patients with this condition. This IND application brings us a step closer to bringing a new and differentiated treatment option for disease modification of the key underlying pathobiology of AMD via the modulation of immune and complement dysfunction,” Mohamed Genead, MD, Co-Founder, CEO & President of Aviceda, said in a company news release.

David Callanan, MD, Aviceda’s Chief Medical Officer, said, “As a retina specialist and ocular immunologist, I am excited about advancing AVD-104 into the clinical phase as we believe that this novel ocular nanoparticle-based therapy will be key in the treatment of this devastating blinding eye disease with enhanced efficacy, safety, and prolonged durability. We anticipate beginning our phase 2 trial as soon as possible after FDA review. This key milestone advances our technology to the clinical phase, and further validates the company’s platform, which includes assets to be directed at neuro-inflammation/degeneration, oncology, fibrosis, and other rare immune pathologies.”