Aviceda Therapeutics announced it submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for AVD-104, a novel glycan-coated nanoparticle intended for intravitreal use, for the treatment of geographic atrophy secondary to age-related macular degeneration.
The US company previously announced the successful completion of IND-enabling Good Laboratory Practice toxicity studies, with positive safety data for multiple well-tolerated doses of AVD-104. This included dose-range-finding studies in non-human primates and rabbits (80 total animals).
Dr David Callanan, Aviceda’s chief medical officer, said he anticipates beginning a 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.”
