ARCHER trial shows benefit of ANX007 on vision loss in geographic atrophy

BARCELONA, Spain — In the phase 2 ARCHER trial, ANX007, a novel C1q inhibitor with neuroprotective properties, showed consistent protection against loss of visual acuity in eyes with geographic atrophy.

One-year study results as well as 18-month extension data were presented by Usha Chakravarthy, MD, PhD, at the Euretina congress.

ANX007 (Annexon Biosciences) was administered intravitreally every month or every other month and compared with a sham injection.

“The primary outcome was the change in GA area measured by fundus autofluorescence, but there were key secondary outcomes that included best corrected visual acuity and low luminance acuity,” Chakravarthy said.

Visual acuity loss was significantly reduced in the two treatment arms compared with the sham arm. More than 20% of sham eyes experienced a loss of 15 letters compared with 5.6% of the eyes treated every month and 9.8% of eyes treated every other month. Similar findings were observed with low luminance visual acuity.

“After 12 months, when the patients came off treatment, these event rates of 15 letter losses started to accumulate faster and reached a similar frequency as the sham arm,” Chakravarthy said.

Over time, retinal pigment epithelium loss was also reduced with treatment compared with sham, showing greater effects with monthly injection.

ANX007 showed positive effects on photoreceptor function, with a 27% lesser decrease compared with sham in the pan-macula and up to 59% in the central 1.5 mm of the macula, the area where photoreceptor density is much greater.

“We have now good biomarkers to assess this, and that’s the [ellipsoid zone], the electron-dense zone of the photoreceptors. This is the first area to be affected by disease,” Chakravarthy said.

ANX007 was well tolerated, with only a few instances of intraocular inflammation that were well controlled with steroid administration. There were no reports of an increase in choroidal neovascularization or cases of vasculitis.

“The phase 3 program has been initiated, and I’m sure we will have more to tell you in the upcoming years,” Chakravarthy said.

Published by:

Sources/Disclosures

Collapse

Source:

Chakravarthy U, et al. Preservation of vision by ANX007 in geographic atrophy (GA): Clinical results from the phase 2 ARCHER trial. Presented at: Euretina congress; Sept. 19-22, 2024; Barcelona, Spain.

Disclosures:
Chakravarthy reports consulting for Annexon Biosciences, Apellis, Aviceda, Boehringer Ingelheim, Hoffmann-La Roche and Unity Biotechnologies.

Read more about

This post was originally published on this site