Annexon to Present Phase 2 ARCHER Baseline Characteristics Associated with Confirmed Best Corrected Visual Acuity 15-Letter Loss in Patients with Geographic Atrophy at ASRS 2026
BRISBANE, Calif., July 14, 2026 (GLOBE NEWSWIRE) -- Annexon, Inc. (NASDAQ:ANNX), a biopharmaceutical company advancing the next generation platform of targeted immunotherapies aimed at neuroinflammatory diseases that impact nearly 10 million people worldwide, today announced an oral presentation on the neuroprotective effect of vonaprument at the American Society of Retina Specialists (ASRS) 44th Annual Scientific Meeting being held July 15–18, 2026 in Montréal, Québec, Canada.
In the Phase 2 ARCHER trial, vonaprument demonstrated significant vision preservation in patients with dry age-related macular degeneration (AMD) with geographic atrophy (GA). An upcoming oral presentation at ASRS will highlight findings from Phase 2 ARCHER that identify baseline factors associated with best corrected visual acuity (BCVA) 15-letter loss, informing the patient population selection for the ongoing Phase 3 ARCHER II trial with topline pivotal data expected in the fourth quarter of 2026. Vonaprument is a first-in-kind, non-pegylated antigen-binding fragment (Fab) designed to block C1q, an aberrant trigger for neurodegeneration in GA.
Oral Presentation
"Baseline Characteristics Associated with Loss of BCVA ≥15 ETDRS Letters in Participants with Geographic Atrophy in the Phase 2 ARCHER Study"
- Presenter: Margaret Chang, M.D., M.S., Retinal Consultants Medical Group
- Date/Time: Saturday, July 18, 2026, at 10:44 am Eastern Daylight Time (EDT)
About Vonaprument (formerly ANX007)
Vonaprument is a clinical-stage investigational antigen-binding fragment (Fab) designed as a first-in-kind therapeutic to selectively inhibit C1q, the initiating molecule of the classical complement pathway and a key driver of neurodegeneration. It is formulated for intravitreal (IVT) administration, with the potential to be the first targeted vision-preserving therapy for GA. Vonaprument involves a differentiated neuroprotective approach designed to protect photoreceptor cells and retinal function by blocking C1q and the entire classical pathway, while allowing for normal immune activity of the lectin and alternative complement pathways. Vonaprument has been granted Fast Track designation from the U.S. Food and Drug Administration (FDA) and is the first therapeutic candidate for the treatment of GA to receive Priority Medicine (PRIME) designation from the European Medicines Agency for the treatment of GA.
About the Phase 2 ARCHER Trial
ARCHER is a successfully completed, randomized, multi-center, double-masked, sham-controlled Phase 2 trial that evaluated vonaprument in a broad population of patients with GA. Across multiple measures, vonaprument consistently preserved visual function and ellipsoid zone retinal structure, reinforcing the therapeutic potential of protecting photoreceptor health early in disease progression. Vonaprument provided statistically significant, time and dose-dependent protection from vision loss as measured by confirmed best corrected visual acuity (BCVA) ≥15-letter loss, the widely accepted and clinically meaningful functional endpoint. Significant protection from vision loss was also shown in other prespecified measures of BCVA and visual function, including low luminance visual acuity (LLVA) and low luminance visual deficit (LLVD). Vonaprument was also shown to protect key retinal structures important for vision, including significant protection of photoreceptors as measured by optical coherence tomography (OCT). Vonaprument was generally well-tolerated through month 12, with no increase in choroidal neovascularization (CNV) rates between the treated and sham arms and no events of retinal vasculitis reported.
About the Phase 3 ARCHER II Trial
ARCHER II is an ongoing global, pivotal, Phase 3 sham-controlled, double-masked trial of vonaprument in 659 patients with GA, a disease driven by early photoreceptor degeneration leading to vision loss. Enrollment was completed in July 2025. The primary endpoint of this two year trial is the proportion of patients with confirmed best corrected visual acuity 15-letter loss at two consecutive visits, measured through month 15. Best corrected visual acuity (BCVA) ≥15-letter loss represents three lines on the standard Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart. Proportion of patients experiencing BCVA ≥15-letter loss is a well-established functional endpoint that has served as the basis for numerous ophthalmology drug approvals by the FDA and European Medicines Agency. Secondary endpoints in ARCHER II include safety, LLVA, and photoreceptor integrity (EZ). A global registration path has been established with U.S. and European regulators for ARCHER II. Topline data are expected in the fourth quarter of 2026.
About Annexon
Annexon Biosciences (NASDAQ:ANNX) is advancing the next generation platform of targeted immunotherapies for nearly 10 million people worldwide living with serious neuroinflammatory diseases. Our founding scientific approach focuses on C1q, the initiating molecule of a potent inflammatory pathway that when misdirected can lead to tissue damage and loss of function in a host of diseases. Our targeted therapies are designed to stop classical complement-driven neuroinflammation at its source to provide meaningful functional benefit and alter the course of disease. Annexon’s mission is to deliver game-changing therapies to patients so that they can live their best lives. To learn more visit annexonbio.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "design," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "positioned," "potential," "predict," "seek," "should," "target," "will," "would" and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to the potential therapeutic benefit of vonaprument; timing of and results from the Phase 3 ARCHER II trial, including expected topline data in the fourth quarter of 2026; and the potential for vonaprument to be the first targeted vision-preserving therapy for GA. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the company’s history of net operating losses; the company’s ability to obtain necessary capital to fund its clinical programs; the potential for delays in the company’s clinical trials; the potential for the company’s product candidates to not receive regulatory approval, including if the FDA and comparable foreign regulatory authorities determine that the company’s submission package is not sufficient or require the company to provide additional data in patients that are not feasible to obtain; the early stages of clinical development of the company’s product candidates; the effects of public health crises on the company’s clinical programs and business operations; the company’s ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company’s product candidates; the company’s reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company’s ability to adequately maintain intellectual property rights for its product candidates. These and other risks are described in greater detail under the section titled "Risk Factors" contained in the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company’s other filings with the Securities and Exchange Commission. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Contact:
Joyce Allaire
LifeSci Advisors
jallaire@lifesciadvisors.com
Media Contact:
Beth Keshishian
917-912-7195
beth@bethkeshishian.com
