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Rallybio Announces Approval of Clinical Trial Applications for Phase 2 Trial of RLYB212 in Pregnant Women at Higher Risk of Alloimmunization and FNAIT
— First Ever Trial in Pregnant Women at Higher Risk of Alloimmunization and FNAIT — — Screening in the Phase 2 Clinical Trial On Track to Initiate in 4Q 2024
About this update from Rallybio Corporation
[{"type":"text","content":"\n— First Ever Trial in Pregnant Women at Higher Risk of Alloimmunization and FNAIT —\n\n— Screening in the Phase 2 Clinical Trial On Track to Initiate in 4Q 2024 —\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, today announced the approval of its clinical trial applications (CTAs) for a Phase 2 clinical trial of RLYB212 in pregnant women at higher risk for HPA-1a alloimmunization and fetal and neonatal alloimmune thrombocytopenia (FNAIT). With these approvals from the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), Rallybio will begin to activate Phase 2 clinical sites and expects to initiate screening of participants in the fourth quarter of 2024.\n\n“Securing these CTA approvals from European health authorities to advance RLYB212 into a Phase 2 trial is a significant achievement. These approvals are a testament to the dedication and innovation of our team and our partners as we advance this first ever program to prevent maternal alloimmunization and FNAIT,” said Stephen Uden, M.D., Chief Executive Officer of Rallybio. “We are activating clinical sites and expect to initiate screening this quarter, which will mark another important step toward achieving our mission to prevent FNAIT and its potentially devastating consequences.”\n\nThe single-arm Phase 2 dose confirmation trial (2024-512651-20/NCT06435845) will be conducted in Belgium, the Netherlands, Norway, Sweden, and the UK, and is designed to assess the pharmacokinetics (PK) and safety of RLYB212, a monoclonal anti-HPA-1a antibody, in a total of eight pregnant women at higher risk for HPA-1a alloimmunization and FNAIT. Secondary objectives include assessments of pregnancy and neonatal/infant outcomes, and the occurrence of emergent HPA-1a alloimmunization. Subcutaneous administration of RLYB212 will be initiated by Gestational Week 16 and will continue every 4 weeks through parturition.\n\n“These approvals recognize Rallybio’s commitment to safely and effectively progress a novel prophylactic approach for preventing alloimmunization in pregnant women at higher FNAIT risk,” said Steven Ryder, M.D., Chief Medical Officer at Rallybio...