Aviceda Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has cleared an IND for its lead intravitreal ocular asset AVD-104, paving the way for the company to initiate a Phase II trial. The drug will be assessed for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The phase trial, named SIGLEC trial, is expected to begin in Q2 2023.

AVD-104 is an intravitreal nanoparticle molecule that inhibits the activity of retinal macrophages and repolarises activated macrophages to their resolution state coupled with inhibition of complement cascade amplification.

This dual mechanism of action treats GA via modulation of inflammatory pathways, according to the Massachusetts, US-based company. Aviceda adds that the drug has demonstrated robust in-vitro/vivo efficacy with inhibition of both inflammatory & complement pathways and the potential for every 4-6-month dosing.

AMD is a cause of vision loss that affects 11 million people in the US. The dry form of AMD is characterised by the development of geographic atrophy (GA) where irreversible progressive destruction of central retinal cells and underlying blood vessels occur due to chronic inflammation.

“The FDA’s acceptance of our IND application to initiate the clinical evaluation of AVD-104 brings us one step closer to introducing a potentially paradigm-shifting treatment for people living with geographic atrophy and macular degeneration,” said Mohamed Genead, M.D., Aviceda’s co-founder, president & CEO.

“The AVD-104 IND clearance marks an important milestone for Aviceda as we continue our track record of execution as the leader in the glycome field. We are thrilled to advance the development of AVD-104 in the U.S. and are working to rapidly enroll patients in the Phase 2 portion of the study. We look forward to presenting additional data later this year.”