Alexion to Initiate P-III CHAMPION-ALS Study Evaluating Ultomiris (ravulizumab) in Amyotrophic Lateral Sclerosis

Shots:

• The P-III CHAMPION-ALS study will assess Ultomiris vs PBO (every q8w following an initial loading dose) in ~350 patients in a ratio (2:1) with sporadic or familial ALS for 50wks. Following 50wks. study, Ultomiris will be evaluated in a 2yr. open-label extension study at 90 sites across NA, EU and Asia-Pacific
• The 1EPs will be changed in ALSFRS-R score and 2EPs include VAFS, respiratory capacity, muscle strength, neurofilament light chain (NfL) serum concentrations and safety
• Ultomiris is a mAb targeting C5 protein in the terminal complement cascade and is an approved therapy in the US, EU and Japan for PNH and in the US for aHUS with the expected initiation of its P-III study in Q1’20

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