Scientific poster
Mitigation of Injection site reactions after subcutaneous administration of Dalcinonacog Alfa (DalcA) in Hemophilia B using preclinical models.
Comparison of human and minipig data and for injection site reaction mitigation.
Prophylactic subcutaneous administration of DalcA, a recombinant factor IX variant with 22-fold enhanced potency compared with BeneFIX, provides stable and protective therapeutics FIX levels in individuals with Hemophilia B. Phase 1 and 2b studies demonstrated DalcA was wll tolerated and efficacious, showing sustained FIX levels and no bleeding events from therapy start through washout. However, some subjects reported mild-to-moderate injection site reaction consisting of pain and/or redness folowwing initial subcutaneous administration. To investigate underlying mechanism, the team examined cutaneous microanatomic, cellular, and proteomic changes after subcutaneous DalcA administration in the HypoSkin® injectable human skin biopsy platform and Göttingen minipigs.
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