Rallybio Receives the CTAs’ Approval for P-II Study of RLYB212 to Treat HPA-1a Alloimmunization and FNAIT
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- Rallybio has received the CTAs’ approval for the P-II Study of RLYB212 for treating pregnant women at higher risk for HPA-1a alloimmunization and fetal & neonatal alloimmune thrombocytopenia (FNAIT). With endorsements from the EMA & MHRA, the company will start activating study sites & anticipated screening participants in Q4’24.
- The P-II study will evaluate the safety & PK of RLYB212 (SC; Gestational wks.16; Q4W through parturition) across Belgium, the Netherlands, Norway, Sweden & the UK, a total of eight pregnant women who are at higher risk for HPA-1a alloimmunization & FNAIT.
- The 2EPs of the study assess pregnancy & neonatal/infant outcomes and monitor the occurrence of HPA-1a alloimmunization.
Ref: Rallybio | Image: Rallybio
Related News:- Rallybio Partners with Johnson & Johnson on Therapeutic Solutions to Prevent Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
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