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Rallybio Reports Positive Data in Its Clinical Program for the Prevention of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
RLYB211, an IV-administered anti-HPA-1a antibody, demonstrates ability to rapidly and safely eliminate HPA-1a mismatched platelets up to 7 days after
About this update from Rallybio Corporation
[{"type":"text","content":"\nRLYB211, an IV-administered anti-HPA-1a antibody, demonstrates ability to rapidly and safely eliminate HPA-1a mismatched platelets up to 7 days after administration\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 announced data from its ongoing Phase 1/2 study of RLYB211 showing significant benefit over placebo. RLYB211, a plasma-derived polyclonal anti-HPA-1a antibody, is being evaluated for the prevention of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT), a potentially life-threatening rare disease that can cause uncontrolled bleeding in fetuses and newborns. There is currently no approved therapy for the prevention or treatment of FNAIT.\n\nExtending previous findings, the new data show that administration of RLYB211 accelerated the elimination of HPA-1ab-positive platelets through 7 days following administration compared with placebo. The study simulated a real-world treatment approach to preventing FNAIT.\n\n“This result reinforces our preventative approach to FNAIT for mothers and babies at-risk for this potentially life-threatening-disease,” said Martin Mackay, Chief Executive Officer of Rallybio. “We are both pleased with the RLYB211 findings and excited to move into the next phase of our FNAIT program by advancing RLYB212.”\n\nThese data support Rallybio’s first-in-human clinical trial of its lead candidate RLYB212, a novel human monoclonal anti-HPA-1a antibody which has the same mechanism of action as RLYB211. Data from the Phase 1/2 RLYB212 trial are anticipated mid-year 2022.\n\n“These new data for RLYB211 add to our understanding of how we might best safely prevent FNAIT by rapidly and completely eliminating antigen from circulation before alloimmunization can occur,” said Dr. Christof Geisen, Institute of Transfusion Medicine and Immunohaematology, German Red Cross Blood Transfusion Service, key collaborator in the RLYB211 study. “With this data to inform future trials this is an important step forward for at-risk families who currently have no approved treatments or therapies to prevent maternal alloimmunization, and therefore the occurrence of FNAIT in babies.”\n\nConsistent with previously reported...