
Avirmax Biopharma announced Feb. 28 that it had begun investigational new drug (IND) enabling studies of ABI-201, a viral vector that delivers three genes with the goal of preventing retinal pathogenesis and preserving visual function.
The company said the genes aim to correct the dysregulation of complement activation; prevent inflammation; protect retinal pigment epithelial cells and photoreceptors; and block retinal neovascularization.
ABI-201 is intended to achieve durable expression of these transgenes after a single intravitreal injection. Avirmax said in vivo studies in multiple animal species have demonstrated the anticipated biological functions of the therapeutic genes.
The company said it expects to submit an IND application to the US FDA for ABI-201 in Q4-2025 for a Phase I/IIa trial in patients with dry age-related macular degeneration (AMD).
Avirmax, of Hayward, California, is also developing ABI-110, an intravitreal gene therapy candidate in Phase I/IIa for wet AMD with polypoidal choroidal vasculopathy (PCV).