Annexon Inc ANNX

SOUTH SAN FRANCISCO, Calif., March 01, 2021 (GLOBE NEWSWIRE) -- Today, Annexon, Inc. (“Annexon”) (Nasdaq: ANNX), a clinical stage biopharmaceutical company developing novel therapies for patients with classical complement-mediated disorders of the body, brain and eye, announced that patient dosing has begun in its Phase 2 ARCHER study of its anti-C1q therapy, ANX007, to treat Geographic Atrophy (GA). GA, also known as atrophic age-related macular degeneration (AMD) or dry AMD, can lead to blindness caused by damaged and dying retinal cells. Currently, there are no approved treatment options to prevent onset or progression of GA.

“We are pleased to have commenced this important Phase 2 trial, advancing ANX007 as a potential therapy for GA, a leading cause of blindness and highly burdensome disease which affects more than five million people worldwide,” said Douglas Love, Esq., president and chief executive officer of Annexon. “This program harnesses our targeted anti-C1q approach, fully inhibiting the classical complement pathway with the aim of halting the damaging immune response and nerve damage that occurs in the eye.”

“Geographic atrophy can have a profound impact on patients who lose their ability to drive, read and carry out normal daily functions,” said Peter K. Kaiser, M.D., Professor of Ophthalmology, Cole Eye Institute, Cleveland Clinic. “Targeting aberrant complement activity associated with the GA process has demonstrated great promise. Evaluating treatments that may reduce the rate of GA lesions growth and preserve visual function is important for these patients that have no treatment options today.”

About the Phase 2 ARCHER Clinical Trial and ANX007

The randomized, multi-center, double-masked Phase 2 trial is designed to evaluate the efficacy and safety of ANX007 in reducing the area of GA as evaluated by fundus autofluorescence (FAF) in patients with GA. Monthly and every other month dosing schedules will be evaluated.

ANX007 is an investigational monoclonal antibody antigen-binding fragment for the treatment of patients with complement-mediated neurodegenerative ophthalmic diseases. Formulated for intravitreal administration, ANX007 is designed to potently bind to C1q and inhibit activation of all downstream components of the classical complement cascade, including C3 and C5, but not to interfere with the normal function of C3 and C5 as part of other complement pathways. In Phase 1 studies, intravitreal ANX007 demonstrated full C1q inhibition at 29 days and was well tolerated by patients.

More information can be found at www.annexonbio.com.

About Annexon, Inc.

Annexon is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye. The company’s pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Annexon is deploying a disciplined, biomarker-driven development strategy designed to identify patients, and to measure target engagement and response to treatment. For more information, visit www.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, statements about: advancement of the company’s clinical and preclinical programs; timing of data from clinical trials; and the implementation of the company’s business model and strategic plans for its business and product candidates, including potential treatment indications and additional indications which the company may pursue. 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 early stages of clinical development of the company’s product candidates; the effects of COVID-19 or other 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 Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020 filed with the Securities and Exchange Commission (SEC) on November 16, 2020 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.

CONTACT: Investor Contacts:
Jennifer Lew, Chief Financial Officer
Annexon Biosciences
jlew@annexonbio.com

Sara Michelmore
smichelmore@macbiocom.com

Media Contacts:
Miriam Mason
Annexon Biosciences
mmason@annexonbio.com

Caroline Rufo, Ph.D.
crufo@macbiocom.com