Aviceda Therapeutics has submitted an investigational new drug (IND) application to the FDA for its lead intravitreal intraocular candidate AVD-104, a novel glycan-coated nanoparticle, to treat geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).
Tell me about AVD-104.
As a glyco-immune therapeutic (GIT), AVD-104 is a sialic-acid coated nanoparticle that targets a specific area of the innate immune response relating to AMD in order to potentially prevent dysregulated activity and activate cellular machinery within retinal tissue back into a reparative state.
The biodegradable nanoparticle is part of Aviceda’s GIT pipeline being developed, with a focus given to the cellular and humoral aspects of inflammatory processes within AMD in an effective and well-tolerated delivery system.
What led to this submission?
The NDA submission follows Aviceda’s successful completion of an IND-enabling Good Laboratory Practice (GLP) toxicity studies that reported positive safety data for multiple well-tolerated doses of AVD-104 in December 2022.
Talk more about these studies.
The dose-ranging finding studies focused on the use of AVD-104 in non-human primates and rabbits—80 animals in total. AVD-104 was found to have a robust in-vitro/vivo efficacy with inhibition of both inflammatory and complement pathways. Further, the data supported the potential for 4 to 6-month dosing.
The positive data also promoted the potential initiation of first-in-human clinical studies for Aviceda’s glycobiology technology platform, which combines with the company’s proprietary nanotechnology to stop the immune system response in AMD and reverse the disease’s pathologic process.
Anything else?
Aviceda has also submitted a Fast Track Designation application for AVD-104, per the FDA’s request.
Significance?
With this NDA submission, Aviceda has taken a major step towards launching its phase 2 human clinical trials and, as a result, the potential to develop the first potential therapy that addresses the underlying causes of AMD.