Annexon Highlights Leadership in Advancing Clinical Research and Education for Guillain-Barré Syndrome (GBS) at American Academy of Neurology (AAN) 2025 Annual Meeting
Oral Plenary Presentation on Tuesday, April 8 Features Phase 3 Data for ANX005, the First Potential Targeted Therapy for GBS, Showing Rapid and Durable Benefit Across Clinical Measures and Time Points
Educational Symposium Focuses on Advancing GBS Care and Role of Classical Complement Pathway
New Disease Education Campaign 'Move GBS Forward' Draws Attention to Life-altering Physical and Mental Impact of GBS
BRISBANE, Calif., April 03, 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 highlights the company's leadership in advancing clinical research and education for GBS at the AAN Annual Meeting taking place April 5–9, 2025, in San Diego, California.
Highlighted activities at the conference include:
An oral plenary session, part of the 'Clinical Trials Plenary' session, for the first placebo-controlled Phase 3 trial in GBS, 'A Phase 3 Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ANX005 in Patients with Guillain-Barré Syndrome (GBS)'.
Presenter: Jeff Allen, MD, Professor of Neurology at the University of Minnesota
Program Number: PL5.006
Date/Time: Tuesday, April 8, 10:30-10:45 a.m. Pacific Time
An educational symposium, 'Advancing GBS Care: Latest Insights into the role of classical complement pathway in GBS,' where experts will discuss the risks associated with GBS, current state of patient care and need for new targeted treatments.
Presenters: Jeff Allen, MD, Professor of Neurology at the University of Minnesota; Avni Kapadia, MD, Assistant Professor of Neurology at Baylor College of Medicine; and Nick Silvestri, MD, FAAN, Professor of Neurology, Associate Dean at University of Buffalo
Date/Time: Tuesday, April 8, 6:00-7:00 p.m. Pacific Time
At AAN (Booth #2133), Annexon is launching a new disease education campaign for healthcare professionals called 'Move GBS Forward,' which is designed to advance awareness and understanding of the sudden and long-term impact of GBS so as to encourage prompt diagnosis and care.
GBS is a neuromuscular emergency that affects at least 150,000 people worldwide each year, with no FDA-approved therapies. This rare autoimmune disease is characterized by rapidly progressing and severe weakness that can lead to complete paralysis, often requiring intensive care and mechanical ventilation.
ANX005 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.
About Annexon
Annexon Biosciences (Nasdaq: ANNX) is developing therapeutics that stop classical complement-driven neurodegeneration 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,' '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: the ability of ANX005 to block C1q activity within a single infusion; 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:
Joyce AllaireLifeSci Advisorsjallaire@lifesciadvisors.com
Media Contact:
Sheryl SeapyReal Chemistry949-903-4750sseapy@realchemistry.com
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More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit Protagonist Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the potential benefits of rusfertide and the timing of rusfertide regulatory submissions. In some cases, you can identify these statements by forward–looking words such as 'anticipate,' 'believe,' 'may,' 'will,' 'expect,' or the negative or plural of these words or similar expressions. 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, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements with Janssen and Takeda, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. 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These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda's global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda's most recent Annual Report on Form 20-F and Takeda's other reports filed with the U.S. Securities and Exchange Commission, available on Takeda's website at: or at Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda's future results. Takeda Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. _____________________________________________________ Kuykendall A et al. Results From VERIFY, a Phase 3, Double-Blind, Placebo (PBO)-Controlled Study of Rusfertide for Treatment of Polycythemia Vera (PV). Oral presentation at: American Society of Clinical Oncology (ASCO) Annual Meeting, June 1, 2025. Chicago, IL. LBA3. PROMIS Fatigue Short Form 8a Total T-Score. MFSAF v4.0 Total Symptom Score 7. View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire. Business Upturn takes no editorial responsibility for the same.
