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Rallybio Announces Clinical Proof-of-Concept Results for RLYB211, an Anti-HPA-1a Polyclonal Antibody for the Prevention of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT), Published in the Journal of Thrombosis and Haemostasis
-- Data Support Potential Use of an Anti-HPA-1a Antibody as Prophylaxis for FNAIT -- -- In March 2023, Rallybio Announced Clinical Proof-of-Concept Achieved
About this update from Rallybio Corporation
[{"type":"text","content":"\n-- Data Support Potential Use of an Anti-HPA-1a Antibody as Prophylaxis for FNAIT --\n-- In March 2023, Rallybio Announced Clinical Proof-of-Concept Achieved for its Lead Product Candidate, RLYB212, a Monoclonal Anti-HPA-1a Antibody, in the First Quarter of 2023 --\n\n\n NEW HAVEN, Conn.--(BUSINESS WIRE)--\nRallybio Corporation (Nasdaq: RLYB) today announced publication of Phase 1 / 2 proof-of-concept results for RLYB211, a polyclonal anti-HPA-1a antibody derived from human plasma for the prevention of FNAIT. FNAIT is a rare and life-threatening bleeding disorder in which maternal alloantibodies directed against fetal platelets can lead to devastating outcomes for the fetus/neonate. There are currently no approved therapies for the prevention or treatment of FNAIT. The findings were published in the Journal of Thrombosis and Haemostasis, the official journal of the International Society on Thrombosis and Haemostasis.\n\n\nRallybio’s randomized, single-blind, placebo-controlled, study investigated the ability of a single dose of intravenous RLYB211 to eliminate HPA-1a-positive platelets transfused into HPA-1a-negative healthy subjects. The platelet transfusion in this study was selected based on the precedent of historical clinical trial designs to assess the efficacy of anti-D prophylaxis, in which the transfusion of antigen positive cells is designed to mimic a catastrophic fetal maternal hemorrhage. As has been shown with anti-D prophylactic agents, the ability of RLYB211 to drive the rapid and complete elimination of antigen positive cells is a surrogate indicator of its potential to prevent maternal alloimmunization, and therefore FNAIT. In Cohort 1, subjects received RLYB211 or placebo one hour after transfusion of HPA-1a positive platelets and in Cohort 1B subjects received RLYB211 or placebo followed by platelet transfusion one week later. Proof-of-concept was defined as ≥90% reduction in platelet elimination half-life compared to placebo.\n\n\nThe publication stated:\n\n\n\nRLYB211 accelerated the elimination of HPA-1a positive platelets versus placebo, with all subjects meeting proof-of-concept criteria for greater than 90% reduction in platelet elimination half-life compared to placebo.\n\n\n\nRapid elimination of transfused platelets was evident 7 days after RLYB211 administration, simulating prophylactic administra...