Annexon outlines ANX007 global pivotal programme for geographic atrophy, beginning mid-2024

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The trial will use vision preservation as a primary outcome measure, according to Annexon

A digitally-rendered image of the earth, with lights representing digital data points all over the globe. Image credit: ©Elaine – stock.adobe.com

Annexon hopes to kick off its global registration program in GA during the first half of 2024. Image credit: ©Elaine – stock.adobe.com

Annexon Inc outlined its strategic priorities for 2024 with late-stage clinical milestones, including global registration in the ANX007 programme for geographic atrophy (GA).

The company noted in its news release that ANX007 is the first therapeutic candidate for the treatment of GA to receive PRIME designation in the EU, which provides early and proactive support to developers of promising medicines that may offer a major therapeutic advantage over existing treatments or benefit to patients without treatment options.

“Our distinct classical complement portfolio has been built over 10 years of research focused on stopping C1q-driven inflammation activated on diseased tissue in complement-mediated diseases of the body, brain and eye,” Douglas Love, president and CEO of Annexon, said in a news release.1 “The robust and consistent functional outcome data generated by our flagship and next-wave programmes has reinforced our founding thesis of stopping the classical complement disease process where it starts."

The company’s pipeline also includes ANX005 for Guillain-Barré syndrome (GBS), and ANX1502 for a range of autoimmune indications.1

“This is a pivotal time for Annexon, with registration programmes for our 2 lead candidates, numerous late- and mid-stage clinical catalysts expected across our portfolio and a strong balance sheet to fuel our priority programs to meaningful inflection points,” Love added in the news release. ‘We are proud of what we’ve accomplished over our decade-long history and are excited by the potential to achieve our goal of bringing transformative therapies to millions of patients with debilitating autoimmune, ophthalmic and neurodegenerative diseases.”

About ANX007

The company said in its news release it hopes to kick off its global registration programme in GA, with vision preservation as the primary outcome measure, during the first half of 2024.1

  • GA is an advanced form of dry age-related macular degeneration (AMD), an eye disease that is the leading cause of vision loss in the elderly, that affects an estimated eight million people globally.
  • In the randomised, multi-centre, double-masked, sham-controlled Phase 2 ARCHER clinical trial, ANX007 was the first and only program to show statistically significant and consistent protection against vision loss in a broad population of patients with GA.1

According to the news release, Annexon plans to initiate ARCHER II, a global, sham-controlled Phase 3 clinical trial in patients with GA in mid-2024. ARCHER II is designed to confirm the results from the Phase 2 ARCHER trial, and potentially expedite the path to regulatory approval in Europe.

The company noted in its news release it also plans to initiate the ARROW clinical trial, an injection-controlled head-to-head study against SYFOVRE (pegcetacoplan injection) in late 2024. ARROW has the potential to underscore ANX007’s unique mechanism of action and provide critical differentiation on visual function.

Reference:

  1. Biosciences A. Annexon Outlines 2024 Priorities with Late-Stage Clinical Milestones Across Upstream Complement Portfolio for Autoimmune, Ophthalmic and Neurodegenerative Diseases. GlobeNewswire News Room. Published January 8, 2024. Accessed January 8, 2024. https://www.globenewswire.com/news-release/2024/01/08/2805026/0/en/Annexon-Outlines-2024-Priorities-with-Late-Stage-Clinical-Milestones-Across-Upstream-Complement-Portfolio-for-Autoimmune-Ophthalmic-and-Neurodegenerative-Diseases.html
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