Rallybio (RLYB) announced the initiation of its Phase 2 clinical trial investigating RLYB212 in pregnant women at higher risk for HPA-1a alloimmunization and fetal and neonatal alloimmune thrombocytopenia FNAIT . Screening is now underway to identify the first or sentinel, pregnant woman for enrollment in the Phase 2 trial. “The initiation of screening in the RLYB212 Phase 2 trial is a significant milestone,” said Stephen Uden, M.D., Chief Executive Officer 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.” “The impact of FNAIT can be devastating for babies, parents, and families, and the need for a safe and effective therapeutic that can prevent maternal alloimmunization and FNAIT is high,” said Dr. Vasilis Sitras, M.D., Head of Department, Fetal Medicine, Oslo University Hospital. “We are excited to participate in the development of RLYB212 as the first ever potential preventative therapeutic and hope that one day, we will see an end to pregnancies impacted by FNAIT.”
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