Rallybio has commenced an open-label Phase II trial of RLYB212 in pregnant women at higher risk for HPA-1a alloimmunisation and foetal and neonatal alloimmune thrombocytopenia (FNAIT).
The trial is currently in the screening phase to identify the first subject.
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The multi-centre, single-arm study was designed to confirm the dosage and assess the pharmacokinetics and safety of RLYB212 when administered subcutaneously. Pregnant women will receive the treatment by gestational week 16, continuing every four weeks until birth.
Its secondary objectives include monitoring pregnancy and neonatal outcomes and the emergence of HPA-1a alloimmunisation.
The trial is structured to enrol participants in three stages, starting with one sentinel pregnant woman, followed by an initial cohort of three, and a second cohort of four, aiming for a total of eight participants.
A review of outcomes for both participants and infants will be conducted prior to the commencement of each new cohort.
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By GlobalDataThe study will recruit participants from the UK, Sweden, Belgium, Norway, and the Netherlands.
Rallybio CEO Stephen Uden said: “The initiation of screening in the RLYB212 Phase II trial is a significant milestone.
“We are thrilled to achieve this critical step towards delivering on our mission to prevent maternal alloimmunisation, 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.”
FNAIT is a rare and potentially fatal condition that can cause severe bleeding in foetuses and newborns due to an immune reaction against a specific platelet antigen.
It occurs when there is an immune incompatibility between an expectant mother and her foetus concerning the human platelet antigen 1.
In November 2023, the company outlined its Phase II trial plans after receiving favourable data from a Phase I study of RLYB212.
