Alexion says Phase 3 ALXN1210 study shows patients can be switched from Solirs
Alexion Pharmaceuticals (ALXN) announced “positive” topline results of a Phase 3 study of ALXN1210, the company’s investigational long-acting C5 complement inhibitor, which show that patients with paroxysmal nocturnal hemoglobinuria “can be effectively and safely switched from treatment with Soliris every two weeks to treatment with ALXN1210 every eight weeks.”
The study demonstrated non-inferiority of ALXN1210 to #Soliris in patients with PNH who had been stable on Soliris based on the primary endpoint of change in lactate dehydrogenase levels, a direct marker of complement-mediated hemolysis in PNH, the company said.
It adds that the study also demonstrated non-inferiority on all four key secondary endpoints: the proportion of patients with breakthrough hemolysis, the change from baseline in quality of life as assessed via the Functional Assessment of Chronic Illness Therapy-Fatigue Scale, the proportion of patients avoiding transfusion, and the proportion of patients with stabilized hemoglobin levels.
In addition, numeric results for all five endpoints favored ALXN1210. Notably, no patients treated with ALXN1210 experienced breakthrough hemolysis compared to five patients treated with Soliris, Alexion said.
It noted that ALXN1210 was generally well tolerated with a safety profile that is consistent with that seen for Soliris. “Once again ALXN1210 met the high bar set by Soliris in a second, large Phase 3 study.
Importantly, we now have robust data that patients with PNH can effectively and safely transition from Soliris to ALXN1210,” said John Orloff, M.D., Executive Vice President and Head of Research & Development at Alexion.
“We are very pleased that the totality of the Phase 3 PNH data in more than 440 patients, which included patients who had never received a complement inhibitor and patients who were stable on Soliris and switched to ALXN1210, shows numeric results favoring ALXN1210 across all primary and key secondary endpoints, including breakthrough hemolysis.
We believe that the differentiated profile of ALXN1210 could be a meaningful improvement for patients and clinicians and look forward to moving rapidly to global regulatory filings in the U.S. and EU in mid-2018, followed by Japan later in the year.”
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