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.
*n.s. = not significant
References
1 Walgaard, et al., 2011. Early recognition of poor prognosis in Guillain-Barré syndrome. Neurology 76:968.
2 The French Cooperative Group on Plasma Exchange in Guillain–Barré Syndrome. Plasma exchange in Guillain–Barré syndrome. Ann Neurol. 1987;22(6):753-761.
3 Hughes RAC, Swan AV, van Doorn PA. Intravenous immunoglobulin for Guillain-Barré syndrome. Cochrane Database Syst Rev. 2014;(9):CD002063.
4 Van der Meché FGA, Schmitz PIM. A randomized trial comparing intravenous immune globulin and plasma exchange in Guillain–Barré syndrome. N Engl J Med. 1992;326(17):1123-1129.
5 Walgaard C, Lingsma HF, Ruts L, et al. Second intravenous immunoglobulin dose in patients with Guillain-Barré syndrome with poor prognosis (SID-GBS): a double-blind, randomized, placebo-controlled trial. Lancet Neurol. 2021;20(4):275-283.
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; ability to bring ANX005 to patients worldwide as soon as possible; the clinical and regulatory status of ANX005; the overall treatment potential of ANX005; the ability to translate the results of the RWE study to a broad population of GBS patients; the timing and outcomes of ongoing and future interactions with regulatory bodies, including the FDA; the adequacy and sufficiency of the RWE data to support marketing application; the anticipated timeline of our planned Biologics License Application (BLA) submission in the first half of 2025; the potential therapeutic benefit of ANX005 or any other product candidates on GBS, or other autoimmune, neurodegenerative and ophthalmic diseases; potential benefit of ANX005, if approved, compared to IVIg/plasma exchange or other existing therapies; and market size for GBS and other therapeutic areas of interest for Annexon. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties