Annexon Reports Positive Phase 3 Topline Results for ANX005 in Guillain-Barré Syndrome
DENVER, Colo., Jun 04, 2024 (247marketnews.com)- Annexon, Inc. (Nasdaq:ANNX) reported positive topline results from its randomized placebo-controlled pivotal Phase 3 trial in patients with Guillain-Barré syndrome (GBS), which met its primary endpoint for ANX005 30 mg/kg achieving a highly statistically significant 2.4-fold improvement on the GBS-disability scale (GBS-DS) at week 8 (proportional odds analysis, p = 0.0058).
“These data represent an important moment for the GBS community and Annexon,” stated Annexon’s president and chief executive officer, Douglas Love. “With the potential to be the first targeted treatment for GBS in the U.S., ANX005 demonstrated consistent improvement and functional benefits on key primary and secondary endpoints. Additionally, we observed in our Phase 3 trial that early treatment with ANX005 resulted in rapid neuroprotection that stopped the advancement of disease and helped GBS patients get better sooner. These results reinforce Annexon’s founding thesis that C1q inhibition is a powerful mechanism of action to stop the progression of neuroinflammation and underscore the potential of ANX005 and our classical complement platform to treat GBS and a host of other diseases of the body, brain and eye.”
Hugh Willison, MBBS, PhD, Professor Emeritus of Neurology at University of Glasgow commented, “In the first placebo-controlled pivotal study in GBS in approximately 40 years, ANX005 demonstrated robust and immediate neuroprotection by inhibiting C1q and suppressing downstream complement components with a single dose during the critical progressive phase of the disease. By directly targeting complement-mediated inflammation, ANX005 has the potential to act early to prevent nerve damage in this acute neurological emergency. The outcomes of this study represent an important breakthrough in effectively tackling GBS and support the potential of ANX005 to address the significant unmet need in this vulnerable patient population.”
David Cornblath, MD, Professor Emeritus of Neurology at Johns Hopkins University School of Medicine added, “This well designed, rigorous Phase 3 study demonstrated that acute and early intervention with ANX005 can deliver clinical benefits across the entire GBS disease spectrum. These data are consistent with the earlier Phase 1b findings, which showed improvements across multiple supportive functional and prognostic measures important to aid patient recovery. Among other outcomes in the Phase 3 trial, patients dosed with 30 mg/kg were able to walk independently one month earlier and removed off a ventilator one month sooner, which are paramount to getting patients back to normal activities of daily living and represent a potentially transformative advancement for the treatment landscape. I am excited by the potential of ANX005 to be the first FDA approved therapy to treat GBS.”
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