New analysis of data from the phase 2 ARCHER trial showed that Annexon Inc’s ANX007 provided statistically significant protection against vision loss in patients with geographic atrophy (GA). The data were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2024 annual Meeting.
ANX007 is a first-in-class, nonpegylated antigen-binding fragment (Fab), delivered by intravitreal injection. It is designed to block C1q and activation of the classical complement cascade locally in the eye. Key takeaways from the ARCHER data included a 73% relative risk reduction in 15-letter loss of best-corrected visual acuity (BCVA), as well as statistically significant slowing of low luminance visual acuity (LLVA) loss at month 12. The trial also showed that ANX007 protected key retinal structures important for vision, demonstrated by a >50% reduction in the number of patients with substantial retinal pigment epithelium (RPE) loss in the fovea.
“We are pleased to present additional clinical data [that show] preservation of both vision and relevant anatomical structures following ANX007 treatment,” said Douglas Love, president and chief executive officer of Annexon. He said the company is planning to initiate a pivotal phase 3 ARCHER II trial against sham control, as well as a pivotal phase 3 head-to-head ARROW trial against pegcetacoplan injection (Syfovre; Apellis) in the second half of 2024.
