Apellis Pharmaceuticals Inc. (Nasdaq:APLS), a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, today announced updated data from its Phase 2 PLAUDIT study of APL-2 in patients with autoimmune hemolytic anemia (AIHA), including cold agglutinin disease (CAD) and warm antibody autoimmune hemolytic anemia (wAIHA). Data from the PLAUDIT trial will be presented in an oral presentation today at the 24th Annual Congress of the European Hematology Association (EHA), held in Amsterdam, the Netherlands.
In the ongoing PLAUDIT study, 13 patients with CAD have been enrolled to receive subcutaneous APL-2 treatment, of which 10 patients have been on APL-2 for at least 168 days. The trial has also enrolled 11 patients with wAIHA, 8 of which were Direct Antiglobulin Test (DAT) C3+ (C3+ wAIHA); 5 of the C3+ wAIHA patients have been on APL-2 for at least 168 days.
“Patients with autoimmune hemolytic anemias on APL-2 have shown improvement both in important hematologic measures and in quality of life scores, particularly in patients with CAD,” said Federico Grossi, CMO, Apellis. “These data provide a clear path to move forward with a Phase 3 trial of APL-2 in patients with CAD, which we anticipate commencing in early 2020. We have also seen hematologic improvements in patients with wAIHA receiving treatment with APL-2 when there is significant involvement of the complement pathway. Apellis will continue to evaluate the potential of APL-2 for patients with C3+ wAIHA.”
Data will be presented by Bruno Fattizzo, Consultant Hematologist at Fondazione IRCCS Ca’ Granda Policlinico Hospital, Milan, Italy. The presentation will be made available through the “Our Scientific Publications & Presentations” page of the Apellis website at: https://apellis.com/publication-presentation.html.
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