Apellis Pharmaceuticals Inc. has reportedly announced the updated data from its key Phase 2 PLAUDIT study of APL-2 in patients with autoimmune hemolytic anemia (AIHA), including warm antibody autoimmune hemolytic anemia (wAIHA) and cold agglutinin disease (CAD).
Sources close to the matter informed that in the current PLAUDIT study, 13 patients with CAD have been recruited to get subcutaneous APL-2 treatment out of which 10 patients have been on APL-2 treatment for minimum 168 days. The clinical study has also registered 11 patients with wAIHA out of which 8 were Direct Antiglobulin Test C3+, while 5 of the C3+ wAIHA patients have been on APL-2 treatment for at least 168 days.
According to CMO of Apellis, Federico Grossi, patients with autoimmune hemolytic anemias on APL-2 treatment have apparently shown improvement both in quality of life scores and vital hematologic measures. These data would provide a clear path to move forward with a key Phase 3 clinical study of APL-2 in patients with CAD, which the company expects to commence in early 2020.
Seemingly, the company has also seen hematologic improvements in patients with wAIHA receiving treatment through APL-2 medication, when there is substantial involvement of the complement pathway. The company will continue to assess the potential of APL-2 treatment for patients with C3+ wAIHA, Grossi said.
Data from the PLAUDIT trial will be unveiled in an oral presentation at the 24th Annual Congress of the European Hematology Association (EHA), held in Amsterdam, Netherlands. Apellis Pharmaceuticals is a clinical-stage biopharmaceutical company which is focused on the development of new therapeutic compounds for the treatment of the disease through the inhibition of the complement system.
Apparently, the data will be presented by Bruno Fattizzo, a Consultant Hematologist of Fondazione IRCCS Ca' Granda Policlinico Hospital in Milan, Italy. This trial reveals that APL-2 treatment has the potential to considerably help patients with autoimmune hemolytic anemias when there is complement involvement, Dr. Fattizzo mentioned.
Source credit: http://investors.apellis.com/news-releases/news-release-details/apellis-pharmaceuticals-presents-data-ongoing-apl-2-phase-2