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Rallybio Announces Proof-of-Concept Achieved for RLYB212, a Novel Monoclonal anti-HPA-1a Antibody to Prevent Fetal and Neonatal Alloimmune Thrombocytopenia
-- RLYB212 Showed Rapid Elimination of Transfused, HPA-1a Positive Platelets in HPA-1a Negative Subjects -- -- Clinical Findings and Safety Profile
About this update from Rallybio Corporation
[{"type":"text","content":"\n-- RLYB212 Showed Rapid Elimination of Transfused, HPA-1a Positive Platelets in HPA-1a Negative Subjects --\n\n-- Clinical Findings and Safety Profile Consistent with Previously Reported Data; Continue to Support the Potential for RLYB212 as a Prophylactic Treatment for FNAIT --\n\n-- Company Expects to Present Results at a Scientific Conference in 2023 --\n\n NEW HAVEN, Conn.--(BUSINESS WIRE)--\nRallybio Corporation (Nasdaq: RLYB) today announced that clinical proof-of-concept has been achieved in a Phase 1b study for RLYB212, an anti-HPA-1a monoclonal antibody for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT). Results show that one week after a single subcutaneous dose, RLYB212 was able to rapidly and completely eliminate transfused, HPA-1a positive platelets in HPA-1a negative subjects.\n\nAdditional findings from the study show:\n\n\nThe reduction in mean platelet elimination half-life was greater than 90% in both RLYB212 dose groups compared to placebo and was dose related.\n\n\nThe broad range of pharmacokinetic and pharmacodynamic data allows substantive modeling to inform dose selection for a future registrational study.\n\n\nRLYB212 was observed to be well-tolerated with no serious adverse events reported.\n\n\nThe Company expects to report data from the Phase 1b clinical study of RLYB212 at a scientific conference in 2023.\n\n“Our FNAIT development program has consistently demonstrated the effectiveness of anti-HPA-1a antibodies to rapidly eliminate HPA-1a positive platelets from the circulation of HPA-1a negative subjects,” commented Róisín Armstrong, Ph.D., Rallybio’s RLYB212 Program Lead. “We’ve also established in published nonclinical studies the association between rapid platelet elimination and prevention of HPA-1a alloimmunization, which can lead to negative and potentially life-threatening outcomes in FNAIT. Collectively, these data reinforce our belief on the potential for an anti-HPA-1a antibody to be a viable approach for preventing FNAIT and we look forward to continued advancement of the RLYB212 development program.”\n\nRallybio also announced today that testing in the multi-dose cohort of its single-center Phase 1 trial in Europe began in the first quarter of 2023. This portion of the Phase 1 study will evaluate safety and pharmacokinetics of RLYB212 based on repeat dosing ov...