Rallybio (NASDAQ:RLYB) announced the commencement of an open-label Phase II trial of RLYB212 in pregnant women at high-risk of HPA-1a alloimmunization and fetal and neonatal alloimmune thrombocytopenia (FNAIT).
FNAIT is a rare and potentially fatal condition that can cause severe bleeding in fetuses and newborns due to an immune response targeting a specific platelet antigen.
The multi-center, single arm study is currently in the screening phase to identify the first participant. The trial is designed to confirm the optimal dosage and evaluate the pharmacokinetics and safety of RLYB212 when administered subcutaneously. Pregnant participants will begin treatment at gestational week 16, with doses repeated every four weeks until birth.
“The initiation of screening in the RLYB212 Phase II trial is a significant milestone,” said Stephen Uden, CEO of Rallybio. “We are thrilled to achieve this critical step towards delivering on our mission to prevent maternal alloimmunization, and FNAIT and its potentially catastrophic consequences. We thank trial participants as well as our dedicated investigators, site staff, and our partners for their commitment to our shared mission. We look forward to providing further updates on the trial’s progress upon dosing of the first participant.”
