Aviceda Therapeutics announced that the FDA has cleared its investigational new drug (IND) application for AVD-104, its lead intravitreal ocular asset for the treatment of geographic atrophy (GA), allowing the company to move forward with a phase 2 trial.
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 age-related macular degeneration (AMD) in order to potentially prevent dysregulated activity and activate cellular machinery within retinal tissue back into a reparative state.
What makes it unique?
Previous treatment strategies have focused on shutting down humoral components of the innate immune response in order to target AMD.
AVD-104 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.
Any clinical data on it yet?
Dose-range finding studies on AVD-104 have focused on its use 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 hypothetically “switch off” the inflammatory cascading response in AMD and potentially reverse the disease’s pathologic process.
What else should I know?
Based on the FDA’s request, Aviceda also submitted a Fast Track designation application for AVD-104; it is still pending approval.
What’s next?
With the FDA’s stamp of approval, Aviceda is undergoing patient enrollment ahead of initiating the phase 2 SIGLEC trial on AVD-104, which is expected to begin in Q2 2023.
Significance?
With AVD-104, Aviceda has the potential to develop the first therapy that addresses the underlying causes of AMD.