Annexon shows new analyses of ANX007 from Phase 2 ARCHER trial on geographic atrophy

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During the Association for Research in Vision and Ophthalmology (ARVO) 2024 meeting, Annexon presented new analyses of ANX007 from the company’s Phase 2 ARCHER trial on geographic atrophy (GA). According to a news release, statistically significant reduction in photoreceptor loss, greater slowing of retinal pigment epithelium (RPE) loss, and more than a 50% reduction in the number of patients with substantial RPE loss in the fovea were reported.¹

“These new data reinforce the impressive vision preservation observed with ANX007 treatment in GA which is demonstrated by multiple measures of visual acuity, including in foveal and non-foveal patients and in low light settings,” said David Boyer, MD, of Retina-Vitreous Associates Medical Group, California, in the release. “Importantly, the statistically significant preservation of photoreceptor anatomy measured by ellipsoid zone change highlights protection of key retinal structures associated with vision. Moreover, protection of the RPE was more robust in lesions near the fovea, a region highly correlated with visual acuity, while slowing of RPE loss as a lagging indicator was more pronounced over time. These encouraging findings along with the generally well-tolerated safety profile with no incidence of vasculitis hold promise to impact loss of visual acuity within the current treatment landscape.”

For Phase 2 analyses, statistically significant and dose dependent protection in best corrected visual acuity (BCVA) at a ≥15-letter loss was reported, as well as a 73% relative risk reduction in BCVA 15-letter loss, which supports time-dependent protection. Statistical significance was also found in the slowing of low luminance visual acuity loss at month 12 of the trial. Protection in both foveal and non-foveal patients from BCVA 15-letter loss were reported. Ultimately, broad-based protection from vision loss was identified in foveal and non-foveal patients,as well as in low light settings.

Additionally, Annexon reported that ANX007 was well-tolerated among participants. No choroidal neovascularization increase was reported comparing the those treated with ANX007 versus the sham. Additionally, no cases of vasculitis was reported.

“We are pleased to present additional clinical data from the ARCHER trial that are the first to show preservation of both vision and relevant anatomical structures following ANX007 treatment,” said Douglas Love, president and CEO of Annexon, in the release. “These data combined with our robust preclinical work underscore the potential of ANX007’s neuroprotective mechanism of action to protect photoreceptor synapses and visual function and deliver differentiated functional benefit for millions of patients. We look forward to advancing ANX007 into registrational Phase 3 trials in GA expected to initiate by mid- and second half of 2024.”

The company also shared new preclinical data on the role of C1q in the pathogenic elimination of photoreceptor synapses and their protection with C1q blockage with GA. Neurodegeneration at sites outside the atrophic areas of the GA retina were observed in postmortem retina of patients with GA in this preclinical evidence. Pharmacological inhibition of C1q protected photoreceptor synapses and preserved retinal function in an animal model of GA and photoreceptor damage as well.

Annexon is now planning to initiate a global pivotal Phase 3 ARCHER II trial in mid-2024, with a pivotal Phase 3 head-to-head ARROW trial against a pegcetacoplan injection, or SYFOVRE, planned in the second half of 2024. The trials are designed to confirm these Phase 2 ARCHER findings, specifically the protection ANX007 provides against vision loss.

Reference:

1. Annexon presents new neuroprotection data showing ANX007 protects vision and vision-associated structures in geographic atrophy at ARVO 2024 annual meeting. News release. Annexon. May 7, 2024. Accessed May 8, 2024. https://ir.annexonbio.com/news-releases/news-release-details/annexon-presents-new-neuroprotection-data-showing-anx007