Aviceda Therapeutics announced that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA).
The IND supports the use of its lead intravitreal ocular asset, AVD-104 (a novel glycan-coated nanoparticle), for the treatment of geographic atrophy (GA) secondary to AMD, the most common blinding eye disease in those over 65 years of age.
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,” said Mohamed Genead, MD, co-founder, CEO, and president of Aviceda.
David Callanan, MD, Aviceda’s CMO, 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.”
About Aviceda Therapeutics
Aviceda is a private biotechnology company located in Cambridge, MA with a proprietary nano-technology HALOS™ platform and an IND-ready ophthalmic lead product for geographic atrophy (GA) secondary to AMD.
AVD-104 is an intravitreal nanoparticle molecule with a unique dual mechanism of action for the treatment of GA through its modulation of critical inflammatory, by directly inhibiting the activity of damaging phagocytic macrophages and repolarizing them to their resolution state, and by inhibiting the amplification of the complement cascade.
AVD-104 has demonstrated robust in-vitro/vivo efficacy with inhibition of both inflammatory & complement pathways with the potential for every 4- 6-month dosing.
Superior safety was demonstrated in multiple animal models including non-human primates with no signs of any intra-ocular inflammation. In addition, AVD-104 has demonstrated equivalent prevention of neovascularization compared to aflibercept (Eylea) in a well-established ocular CNV model. In addition to AVD-104, Aviceda has a broad pipeline of products in development in ophthalmology and other therapeutic areas such as neurology, oncology, fibrosis, and immunology.