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Rallybio Announces Publication of RLYB212 Phase 1 Proof-of-Concept Study Results in Thrombosis and Haemostasis
– Study Demonstrates that RLYB212 Rapidly Clears HPA-1a Positive Platelets, an Essential Step in Preventing Alloimmunization and FNAIT – – Rallybio On Track
About this update from Rallybio Corporation
[{"type":"text","content":"\n– Study Demonstrates that RLYB212 Rapidly Clears HPA-1a Positive Platelets, an Essential Step in Preventing Alloimmunization and FNAIT –\n\n\n– Rallybio On Track to Initiate RLYB212 Phase 2 Dose Confirmation Trial in Pregnant Women at Higher Risk for FNAIT in 4Q 2024 –\n\n\n NEW HAVEN, Conn.--(BUSINESS WIRE)--\nRallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, announced today that data from the Phase 1 proof-of-concept study of RLYB212, a novel monoclonal anti-HPA-1a antibody in development for the prevention of maternal alloimmunization and fetal and neonatal alloimmune thrombocytopenia (FNAIT), were published in Thrombosis and Haemostasis. Top-line results from this study were previously presented at the 31st Congress of the International Society on Thrombosis and Haemostasis (ISTH) in 2023.\n\n\n“These data were instrumental in our selection of the initial dose for the upcoming Phase 2 trial of RLYB212, which is on track for initiation in the fourth quarter of 2024,” said Stephen Uden, M.D., Chief Executive Officer of Rallybio. “Our primary focus is to advance RLYB212 through development with a goal of bringing a new therapy to a completely underserved area of maternal fetal health.”\n\n\nData from the Phase 1 proof-of-concept study demonstrated that subcutaneous administration of RLYB212 produced a dose-dependent, rapid, and complete elimination of transfused HPA-1a positive platelets in HPA-1a negative subjects, with both doses (0.09 mg and 0.29 mg) meeting the prespecified proof-of-concept criteria of ≥90% reduction in mean platelet elimination half-life as compared to placebo. These data along with a significant body of preclinical data generated to date were critical to the establishment of therapeutic exposure targets that Rallybio believes will safely and effectively prevent maternal alloimmunization to fetal antigen, the prerequisite event leading to FNAIT.\n\n\nThe bolus challenge of HPA-1a positive platelets was designed as a surrogate for a large 30 mL fetal-maternal hemorrhage. Platelet elimination profiles after subcutaneous administration of RLYB212 were consistent with those of Rhesus factor D (RhD)-positive erythrocytes after intramuscular administration of anti-RhD agents, whi...