28.11.2023 13:38:18
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Rallybio Reports Preliminary Data From Phase 1 Study For RLYB212 - Quick Facts
(RTTNews) - Rallybio Corp. (RLYB) reported preliminary data from the completed multiple dose cohort of the Phase 1 safety and pharmacokinetics study for RLYB212, an anti-HPA-1a monoclonal antibody for the prevention of fetal and neonatal alloimmune thrombocytopenia. The preliminary data showed that multiple dose PK were consistent both within and between subjects. The preliminary data and the company's clinical pharmacology modeling predictions support a once monthly dosing regimen for the planned Phase 2 study.
Rallybio also said the RLYB212 toxicology package to support the planned Phase 2 and Phase 3 studies, including the maternal fetal toxicology program, is complete.
Risn Armstrong, Rallybio's RLYB212 Program Lead, said: "We are now focused on initiating the Phase 2 dose confirmation study in pregnant women at higher risk of FNAIT in the second half of 2024."
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