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Rallybio Announces Proof-of-Concept Results and Development Updates for RLYB212, a Novel Monoclonal anti-HPA-1a Antibody to Prevent Fetal and Neonatal Alloimmune Thrombocytopenia
-- RLYB212 Demonstrated Dose-Dependent, Rapid and Complete Elimination of Transfused HPA-1a Positive Platelets in HPA-1a Negative Subjects -- -- Mean
About this update from Rallybio Corporation
[{"type":"text","content":"\n -- RLYB212 Demonstrated Dose-Dependent, Rapid and Complete Elimination of Transfused HPA-1a Positive Platelets in HPA-1a Negative Subjects --\n\n-- Mean Reduction in Platelet Elimination Half-Life After Subcutaneous Administration of RLYB212 was ≥90% in both RLYB212 Dose Groups, Achieving Proof-of-Concept Criteria --\n\n-- Phase 2 Study in Pregnant Women at Higher Risk of HPA-1a Alloimmunization to be Initiated in 2H 2024 --\n\n-- Phase 1 Multiple Dose Data and Maternal-Fetal Toxicology Data On-track for 4Q 2023 --\n\n-- Company to Host Investor and Analyst Meeting Webcast with Corresponding Slides at 4:00pm ET --\n\n NEW HAVEN, Conn.--(BUSINESS WIRE)--\nRallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare diseases, today reported data from the Phase 1b proof-of-concept study of RLYB212, a novel monoclonal anti-HPA-1a antibody in development for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT). The data, delivered in an oral presentation by Christof Geisen, M.D., at the 31st Congress of the International Society on Thrombosis and Haemostasis (ISTH), showed that subcutaneous (SC) RLYB212 administration produced a dose-dependent, rapid and complete elimination of transfused HPA-1a positive platelets in HPA-1a negative subjects, with both doses meeting the prespecified proof-of-concept criteria of ≥90% reduction in mean platelet elimination half-life. Mean platelet elimination half-life was 5.8 hours (0.09mg) and 1.5 hours (0.29mg) for RLYB212 compared to 71.7 hours for placebo.\n\nChristof Geisen, M.D., Institute of Transfusion Medicine and Immunohaematology, German Red Cross Blood Transfusion Service, and the lead author for the RLYB212 abstract stated, “These proof-of-concept results provide further understanding as to how FNAIT may have the potential to be prevented through the rapid and complete elimination of fetal platelet antigens prior to maternal alloimmunization. These data are a critical step forward to address a significant unmet need with no currently approved treatments or therapies to prevent maternal alloimmunization as well as the occurrence of FNAIT in babies.”\n\nPhase 1b Proof-of-Concept (POC) Study of RLYB212 in FNAIT\n\nThe Phase 1b single...