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AZN : Phase III Trial Of Ultomiris Meets Main Goal In Neuromyelitis Optica Spectrum Disorder

AstraZeneca Plc (AZN,AZN.L) said phase III CHAMPION-NMOSD trial results showed that Ultomiris or ravulizumab-cwvz achieved a statistically significant and clinically meaningful reduction in the risk of relapse i n adults with anti-aquaporin-4 antibody-positive (Ab+) neuromyelitis optica spectrum disorder or NMOSD compared to the external placebo arm from the pivotal Soliris PREVENT clinical trial.

According to the company, Ultomiris, long-acting C5 complement inhibitor, met the primary endpoint of time to first on-trial relapse, as confirmed by an independent adjudication committee. Notably, no relapse was observed in 58 patients over a median treatment duration of 73 weeks.

NMOSD is a rare disease in which the immune system is inappropriately activated to target healthy tissues and cells in the CNS. Approximately three-quarters of people with NMOSD are anti-AQP4 Ab+, meaning they produce antibodies that bind to a specific protein, aquaporin-4 (AQP4).

The binding can inappropriately activate the complement system, which is part of the immune system and is essential to the body's defence against infection, to destroy cells in the optic nerve, spinal cord and brain.

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