Annexon to Present New Phase 2 ARCHER Data for ANX007 in Dry AMD Patients with Less Advanced GA at the American Academy of Ophthalmology 2024 Meeting

Rhea-AI Summary

Annexon, Inc. (Nasdaq: ANNX) will present new analyses of ANX007 from the completed Phase 2 ARCHER trial in geographic atrophy (GA) at the American Academy of Ophthalmology (AAO) 2024 annual meeting and the Eyecelerator conference at AAO. ANX007, a first-in-kind, non-pegylated antigen-binding fragment (Fab), is designed to block C1q locally in the eye with an intravitreal formulation.

Key highlights include:

• ANX007 demonstrated significant vision protection in standard and low light conditions
• Significant photoreceptor preservation was observed in the fovea region critical for visual acuity
• Phase 3 data from the ongoing ARCHER II pivotal program is expected in the second half of 2026

Presentations will be made by Dr. Rahul N. Khurana and Douglas Love at the respective events in Chicago, Illinois.

Positive

• ANX007 demonstrated significant vision protection in standard and low light conditions
• Significant photoreceptor preservation observed in the fovea region critical for visual acuity
• Ongoing Phase 3 ARCHER II pivotal program, with data expected in second half 2026

Negative

• None.

Insights

Medical Research Analyst

The presentation of new Phase 2 ARCHER data for ANX007 in dry AMD patients with less advanced GA is a significant development for Annexon. Key points include:

• ANX007 showed significant vision protection in standard and low light conditions
• Significant photoreceptor preservation in the fovea region, which is critical for visual acuity
• Phase 3 data from the ongoing ARCHER II pivotal program is expected in the second half of 2026

This data suggests potential efficacy for ANX007 in treating geographic atrophy, a severe form of age-related macular degeneration. The preservation of vision and photoreceptors in the fovea is particularly important, as this region is important for central vision.

However, investors should note that while these Phase 2 results are promising, the Phase 3 data, which will be more definitive, is still about two years away. This timeline implies a relatively long path to potential commercialization, if successful.

The presentation at the prestigious American Academy of Ophthalmology meeting provides visibility and peer validation for Annexon's approach, potentially increasing interest from both the scientific community and investors in the ophthalmology space.

ANX007 Demonstrated Significant Vision Protection in Standard and Low Light Conditions and Significant Photoreceptor Preservation in the Fovea Region Critical for Visual Acuity

Phase 3 Data from Ongoing ARCHER II Pivotal Program Expected Second Half 2026

BRISBANE, Calif., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company focused on upstream C1q to advance therapies for neuroinflammatory diseases of the body, brain and eye, today announced the Company will present new analyses of ANX007 from the completed Phase 2 ARCHER trial in geographic atrophy (GA) at the American Academy of Ophthalmology (AAO) 2024 annual meeting being held October 18-21 in Chicago, Illinois, and at the Eyecelerator conference at AAO being held Thursday, October 17, 2024. ANX007 is a first-in-kind, non-pegylated antigen-binding fragment (Fab) designed to block C1q locally in the eye with an intravitreal formulation.

Details of the presentations are as follows:

American Academy of Ophthalmology 2024 Annual Meeting
“Preservation of Vision by ANX007: Clinical Results and Anatomical Changes from the Phase 2 ARCHER Trial”

• Session: Poster discussion
• Presenter: Dr. Rahul N. Khurana, Northern California Retina Vitreous Associates and UCSF Medical Center Department of Ophthalmology, California, US
• Date/Time: Monday, October 21, 2024, 9:15am CDT
• Location: McCormick Place, Chicago, US

2024 Eyecelerator Conference at AAO
“AAO 2024 Retina Showcase”

• Session: Corporate presentation and panel discussion
• Presenter: Douglas Love, Annexon Biosciences
• Date/Time: Thursday, October 17, 2024, 2:27pm CDT
• Location: McCormick Place, Chicago, US

About ANX007 and Phase 2 ARCHER Trial
ANX007 is an antigen-binding fragment (Fab) antibody 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. In dry age-related macular degeneration (AMD) or geographic atrophy (GA), C1q binds to photoreceptor synapses early in the disease process, causing aberrant activation of the classical pathway with synapse loss, inflammation and neuronal damage that results in vision loss. Intravitreal administration of ANX007 fully stopped C1q and classical pathway activation. In animal models, the murine analog of ANX007 protected against loss of photoreceptor synapses and cells to preserve function. ANX007 has been granted Fast Track designation from the Food and Drug Administration and is the first therapeutic candidate for the treatment of GA to receive Priority Medicine (PRIME) designation in the EU, which provides early and proactive support to developers of promising medicines that may offer a major therapeutic advantage over existing treatments or benefit to patients without treatment options.

In the randomized, multi-center, double-masked, sham-controlled Phase 2 ARCHER clinical trial, ANX007 demonstrated consistent protection against vision loss across multiple measures in a broad population of patients with GA. ANX007 provided statistically significant, time and dose-dependent protection from vision loss as measured by ≥ 15 letter loss on reading an eye chart with best corrected visual acuity (BCVA≥15), 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). ANX007’s treatment effect increased over the course of the on-treatment portion of the study, suggesting that ANX007 may provide a growing and durable treatment effect over time. While benefit gained against vision loss was maintained during the subsequent six-month off-treatment period, the rate of decline for BCVA ≥ 15-letter vision after treatment termination began to parallel that of sham, providing additional support for the observed on-treatment protection. ANX007 was also shown to protect key retinal structures important for vision, including significant protection of photoreceptors as measured by optical coherence tomography (OCT) and supported by slowing of loss of retinal pigment epithelial cells (RPE) near the fovea, as measured by fundus autofluorescence (FAF). ANX007 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 Dry AMD and Geographic Atrophy
Dry age-related macular degeneration (AMD) is the most common form of AMD and geographic atrophy (GA) is an advanced form of dry AMD, an eye disease that is the leading cause of blindness in the elderly. GA is a chronic progressive neurodegenerative disorder of the retina involving the loss of photoreceptor synapses and cells in the outer retina. GA affects an estimated one million people in the United States and eight million people globally, severely limiting their independence and causing frustration, anxiety and emotional hardship. Effective treatments that preserve vision are still needed, as no currently approved therapies have been shown in clinical trials to significantly prevent vision loss.

About Annexon
Annexon Biosciences (Nasdaq: ANNX) is harnessing neuroinflammation to advance potentially first-in-kind treatments for millions of people living with serious neuroinflammatory diseases of the body, brain and eye. Our novel scientific approach focuses on C1q, the initiating molecule in the part of the immune system that protects against infection. By targeting C1q, our immunotherapies are designed to stop neuroinflammatory diseases where they start. Our pipeline spans three diverse therapeutic areas – neurodegenerative, ophthalmic and autoimmune diseases – and includes investigational drug candidates designed to address the unmet needs of over 8 million people worldwide. Annexon’s mission is to deliver potentially game-changing therapies to patients so that they can live their best lives. When they thrive, we thrive. 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,” “suggest,” “target,” “on track,” “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 ability of ANX007 to block upstream C1q; the clinical and regulatory status of ANX007; ANX007’s distinct potential neuroprotective mechanism of action and potential to provide protection from vision loss; the potential therapeutic benefit of ANX007; Annexon’s ability to stop neuroinflammatory diseases where they start; and Annexon’s ability to deliver game-changing therapies to over 8 million people. 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 ongoing off-treatment follow-up portion of the Phase 2 ARCHER trial; the company’s history of net operating losses; the company’s ability to obtain necessary capital to fund its clinical programs; 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 SEC. 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, LLC
jallaire@lifesciadvisors.com

Media Contact:
Sheryl Seapy
Real Chemistry
949-903-4750
sseapy@realchemistry.com

FAQ

What are the key findings from Annexon's Phase 2 ARCHER trial for ANX007 in dry AMD patients?

The Phase 2 ARCHER trial showed that ANX007 demonstrated significant vision protection in standard and low light conditions, and significant photoreceptor preservation in the fovea region critical for visual acuity in dry AMD patients with less advanced geographic atrophy (GA).

When is Annexon (ANNX) expecting Phase 3 data for ANX007 in geographic atrophy?

Annexon (ANNX) is expecting Phase 3 data from the ongoing ARCHER II pivotal program for ANX007 in geographic atrophy in the second half of 2026.

Where and when will Annexon (ANNX) present the new Phase 2 ARCHER data for ANX007?

Annexon (ANNX) will present the new Phase 2 ARCHER data for ANX007 at the American Academy of Ophthalmology (AAO) 2024 annual meeting and the Eyecelerator conference at AAO, held from October 17-21, 2024, in Chicago, Illinois.

What is ANX007 and how does it work in treating geographic atrophy?

ANX007 is a first-in-kind, non-pegylated antigen-binding fragment (Fab) designed to block C1q locally in the eye with an intravitreal formulation. It aims to treat geographic atrophy by targeting upstream C1q to address neuroinflammatory diseases of the eye.