Alexion announced that is plans to start a Phase 3 study of ULTOMIRIS (ravulizumab) in amyotrophic lateral sclerosis (ALS).
Alexion (NASDAQ:ALXN) announced that is plans to start a Phase 3 study of ULTOMIRIS (ravulizumab) in amyotrophic lateral sclerosis (ALS).
As quoted in the press release:
The 50-week global study, called CHAMPION-ALS, will evaluate approximately 350 adults across a broad patient population, and the primary endpoint will be change in ALS functional rating scale-revised (ALSFRS-R) score. Alexion submitted an investigational new drug application (IND) for ULTOMIRIS in ALS to the FDA in the fourth quarter of 2019 and plans to initiate the Phase 3 study this quarter.
“Given the significant need for new and improved treatments for ALS, we are committed to advancing this clinical program with urgency,” said John Orloff, M.D., Executive Vice President and Head of Research & Development at Alexion. “Based on preclinical data and the significant role complement activation is known to play in other neuromuscular diseases, we believe ULTOMIRIS has the potential to inhibit complement-mediated damage in people with ALS, which may slow disease progression. We thank the ALS community for their involvement in designing this Phase 3 program and look forward to continued close collaboration as we move it forward.”