Annexon To Present Pivotal Phase 3 Data On Early And Durable Benefits With First-In-Class C1q Blocking Antibody ANX005 In Guillain-Barré Syndrome At 2024 PNS Annual Meeting

2024-06-18

临床3期孤儿药快速通道临床结果

Single Infusion of ANX005 Demonstrated Significant Improvements Across Multiple Functional and Prognostic Measures That Expedited Recovery in GBS Patients ANX005 Has Potential to be the First Targeted Therapy Approved for the Treatment of GBS BRISBANE, Calif., June 18, 2024 (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 the Company will have several presentations on the Company’s ANX005 Guillain-Barré Syndrome (GBS) program at the 2024 Peripheral Nerve Society (PNS) Annual Meeting being held June 22-25, 2024 at the Palais des congrès de Montréal in Montréal, Canada. Pivotal Phase 3 clinical results of ANX005 in GBS, including further analyses of early and durable treatment effects on measures important to patients and the medical community, will be highlighted as part of a plenary clinical presentation, as well as discussed in an Annexon sponsored lunch symposium, a flash oral presentation, and two poster presentations. Details of the presentations are as follows: Oral Presentation: “Design of a Phase 3 Study Evaluating ANX005 in Patients with Guillain-Barré Syndrome” Abstract #: O 442 Session: The Richard A.C. Hughes Symposium: Clinical Highlights Presenter: Dr. Quazi Deen Mohammad, National Institute of Neuroscience, Bangladesh Date/Time: Tuesday, June 25, 2024, 4:59 – 5:12 p.m. EDT Location: Main Plenary Hall Annexon Lunch Symposium: “Annexon Biosciences Breaking New Ground in the GBS Treatment Landscape” Presenters: Dr. David Cornblath, Johns Hopkins University School of Medicine, USA; Dr. Bart Jacobs, Erasmus MC, Netherlands; Dr. Luis Querol, Hospital de la Santa Creu i Sant Pau, Spain; Dr. Jeff Allen, University of Minnesota, USA; Lisa Butler, GBS|CIDP Foundation International, USA Time and date: Tuesday, June 25, 2024, 1:15 – 2:15 p.m. EDT Location: Room 710b Flash Oral Presentation: “Comparative Efficacy: ANX005's Potential Advantage over Intravenous Immunoglobulin in Guillain-Barré Syndrome” Abstract #: 83890 Session: Inflammatory Neuropathy Consortium (INC) Concurrent SIG – INC Flash Presentations Presenter: Dr. Henk-André Kroon, Annexon Biosciences, USA Time and date: Sunday, June 23, 2024, 4:25 – 4:30 p.m. EDT Location: Room 517d Poster Presentation: “Coexistence of Acute Motor Axonal Neuropathy and Acute Inflammatory Demyelinating Polyneuropathy in Guillain-Barré Syndrome” Abstract #: P 238 Session: Poster Session II Presenter: Dr. Henk-André Kroon, Annexon Biosciences, USA Date/Time: Monday, June 24, 2024, 2:15 – 3:15 p.m. EDT Location: Poster Hall Poster Presentation: “Development of a Framework to Compare Outcomes Between Diverse GBS Populations” Abstract #: P 305 Session: Poster Session I Presenter: Dr. Eveline J.A. Wiegers, Erasmus MC, Netherlands Date/Time: Sunday, June 23, 2024, 2 – 3 p.m. EDT Location: Main Plenary Hall Additional details are available on the 2024 PNS Annual Meeting website here. About ANX005 Annexon’s lead investigational therapy, ANX005, is a first-of-its kind selective, targeted and rapid-acting agent designed to reduce inflammation and nerve damage by fully stopping C1q activity in the peripheral and central nervous systems. In GBS, ANX005 seeks out C1q and selectively blocks it from binding to its target on peripheral nerves. ANX005 is administered intravenously and has been observed to act almost immediately. In GBS, the aim is to rapidly stop the autoimmune damage of nerve cells, allowing patients to regain muscle strength sooner to regain independence and return to pre-illness activities. ANX005 has received both fast track and orphan drug designations from the U.S. Food and Drug Administration as well as orphan drug designation by the European Medicines Agency for the treatment of GBS. About Guillain-Barré Syndrome (GBS) GBS is a severe disease resulting from an acute autoantibody attack on peripheral nerves that generally occurs post-infection in otherwise healthy persons following activation of C1q and the classical complement cascade. It is a rapid and acute neurological disease with a narrow therapeutic window that results in hospitalization of over 22,000 people annually in the U.S. and Europe. The peripheral nerve damage progresses rapidly, causing acute neuromuscular paralysis, and may 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. About Annexon Annexon Biosciences (Nasdaq: ANNX) is 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. Annexon’s novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and geographic atrophy, Annexon is rigorously advancing its mid-to late-stage clinical trials to bring their potential treatments to patients as quickly as possible. 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, statements about: ability of ANX005 to stop C1q activity; the clinical and regulatory status of ANX005; the potential of ANX005 to be the first approved treatment for GBS; the potential therapeutic benefit of ANX005 on GBS; potential benefit of ANX005, if approved, compared to existing therapies; the potential benefits from treatment with anti-C1q therapy; and Annexon’s ability to rigorously advance mid-to late-stage clinical trials and continue development 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 potential for any final clinical trial results to differ from preliminary or topline results; 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