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Friday / June 14.
HomeminewsImproved Vision Reported in GA Clinical Trial

Improved Vision Reported in GA Clinical Trial

Annexon has reported its geographic atrophy (GA) medication ANX007 failed a clinical trial goal but did achieve “statistically significant protection against vision loss in both foveal and non-foveal patients through 12 months”.

The biopharmaceutical company has announced topline results from its ARCHER Phase 2 trial of ANX007 in patients with GA.1

The company said the primary endpoint of mean rate of change in GA lesion area compared to sham at 12 months did not reach statistical significance. However, Annexon will push ahead with the drug after the trial produced other “promising” data.

Treated patients reported improved vision as measured by their ability to read three lines of letters on a common vision test, especially those who received ANX007 once a month.

we believe that ANX007 has the potential to be a new and distinct treatment option for patients with GA

The trial found that patients given 5mg of ANX007 had a 72% reduction in 15-letter loss, compared to placebo. Patients given the same dose of the drug every other month had a 48% reduction.

Ultimate Clinical Goal

“Based on the totality of the topline data from the ARCHER trial, we believe that ANX007 has the potential to be a new and distinct treatment option for patients with GA, marking an important step toward achieving our mission of delivering game-changing therapies to patients living with complement-mediated diseases,” said Douglas Love, chief executive officer of Annexon.

“Protecting against vision loss for patients with GA is the ultimate clinical goal. Based on the ARCHER trial results, we plan to engage with regulators to determine the optimal path forward to bring ANX007 to patients as expeditiously as possible.”

The phase 2 ARCHER trial enrolled 270 patients and randomised them to receive 5mg of ANX007 once a month, 5mg once every other month, or a placebo either once a month or once every other month. The average age of enrolled patients was 80.

Geographic atrophic age-related macular degeneration is a leading cause of vision loss and blindness.

Until recently, there was no treatment. However, Annexon is now chasing Apellis Pharmaceuticals, which recently received US Food and Drug Administration (FDA) approval for Syfovre (pegcetacoplan injection) for GA and Iveric Bio, whose GA med has a mid-August FDA approval decision deadline.

 

Reference

  1. Annexon Biosciences, Annexon topline data from ARCHER Phase 2 trial of ANX007 in geographic atrophy demonstrated statically significant, dose-dependent preservation of visual function (news release), 24 May 2023, available at: ir.annexonbio.com/news-releases/ [accessed 29 May 2023].