Annexon Announces Presentations on the Clinical Advancement of Tanruprubart as the First Potential Targeted Therapy for Guillain-Barré Syndrome (GBS) at the 2025 PNS Meeting
First Oral Presentation by the International Guillain-Barré Syndrome Outcomes Study (IGOS) of the Real-World Evidence (RWE) Results Showing Improved Outcomes with Tanruprubart (formerly ANX005) Compared to Current Standards of Care in Matched Patient Populations
New Analyses of Phase 3 Trial Highlight Tanruprubart's Early and Durable Treatment Effect and Improvement in Quality of Life in Patients with GBS
BRISBANE, Calif., May 09, 2025 (GLOBE NEWSWIRE) -- Annexon, Inc. (NASDAQ:ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today announced oral and poster presentations highlighting improved outcomes with tanruprubart (formerly ANX005) at the 2025 Peripheral Nerve Society (PNS) Annual Meeting at the Edinburgh International Conference Centre being held May 17-20, 2025 in Edinburgh, UK.
GBS is a neuromuscular emergency and rare autoimmune disease with no FDA-approved therapies that is characterized by rapidly progressing and severe weakness that can lead to complete paralysis, often requiring intensive care and mechanical ventilation. Tanruprubart is a first-in-kind monoclonal antibody designed to block C1q, the initiating molecule of the classical complement cascade, with a single infusion to halt ongoing neuroinflammation and nerve damage in the acute phase of GBS to improve and expedite overall recovery.
Oral Presentation
"Comparative Effectiveness in IGOS: ANX005 Versus Intravenous Immunoglobulin or Plasma Exchange for Guillain-Barré Syndrome"
- IGOS Presenter: Eveline Wiegers, M.D., Ph.D.
- Date/Time: Monday, May 19, from 3:55 pm to 4:10 pm British Summer Time (BST)
Poster Presentations
"Linking Early Complement Inhibition to Long-Term Outcomes in GBS: Objective Measures Support Tanruprubart (ANX005) Efficacy"
- Presenter: Glenn Morrison, Ph.D.
- Date/Time: Sunday May 18, from 2:30 pm to 3:20 pm BST
"Tanruprubart (ANX005) Improves Health-related Quality of Life in Patients with Guillain-Barré Syndrome Compared to Placebo"
- Presenter: Glenn Morrison, Ph.D.
- Date/Time: Monday, May 19, from 2:10 pm to 3:10 pm BST. Poster also selected as a flash oral presentation from 5:30 pm to 5:35 pm BST.
"Efficacy of Tanruprubart (ANX005) for Treatment of Guillain-Barré Syndrome in a Broad Spectrum of Patients"
- Presenter: Henk-André Kroon, M.D.
- Date/Time: Monday May 19, from 2:10 pm to 3:10 pm BST
About Tanruprubart (formerly ANX005)
Annexon's lead investigational therapy, tanruprubart, is a first-of-its kind selective, targeted and rapid-acting agent designed to reduce inflammation and nerve damage by stopping C1q activity in the peripheral and central nervous systems. In GBS, tanruprubart is designed to seek out C1q and prevent its binding to targets on peripheral nerves. Tanruprubart is administered intravenously and has been observed to act almost immediately in blocking C1q function. The aim of an effective treatment in GBS is to rapidly stop the autoimmune damage on nerve cells, allowing patients to regain muscle strength sooner and to regain independence and return to pre-illness activities. Tanruprubart has received both Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration as well as orphan drug designation from the European Medicines Agency for the treatment of GBS.
About Guillain-Barré Syndrome (GBS)
GBS is a rare neuromuscular emergency resulting from an acute autoantibody and classical complement-mediated attack on peripheral nerves that generally occurs post-infection in otherwise healthy persons. It is an acute, rapidly progressive disease with a narrow timeframe for therapeutic intervention. GBS results in the hospitalization of more than 22,000 people annually in the U.S. and Europe. The peripheral nerve damage progresses rapidly, causing acute neuromuscular paralysis that can lead to significant morbidity, disability and mortality. Currently, there are no approved treatments for GBS in the U.S. The long-term disease burden associated with GBS has led to a multi-billion-dollar annual economic cost to the U.S. healthcare system alone. More information about the impact of GBS is available at MoveGBSForward.com.
About Annexon
Annexon Biosciences (NASDAQ:ANNX) is developing therapeutics that stop classical complement-driven neuroinflammation as 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 of classical complement's potent inflammatory pathway that when misdirected can lead to tissue damage and loss. By targeting C1q, our immunotherapies are designed to stop this neuroinflammatory cascade in disease before it starts. Our pipeline spans three diverse therapeutic areas – autoimmune, neurodegenerative and ophthalmic diseases – and includes targeted investigational drug candidates designed to address the unmet needs of over 8 million people worldwide. 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," "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 tanruprubart (formerly ANX005) to stop C1q activity in the peripheral and central nervous systems; the clinical and regulatory status of ANX005; and the potential therapeutic benefit of ANX005; the potential benefits from treatment with anti-C1q therapy; and continuing advancement of the company's portfolio. 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 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:
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Media Contact:
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Real Chemistry
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