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US-based biotechnology company Rallybio has dosed the first subject in a Phase II trial evaluating RLYB212 as a potential treament for foetal and neonatal alloimmune thrombocytopaenia (FNAIT).
The single-arm, dose confirmation trial aims to assess RLYB212's pharmacokinetics (PK) and safety in pregnant women who are at a higher risk for human platelet antigen (HPA) 1a alloimmunisation and FNAIT.
Initial data from the second trimester are expected to be available by the second quarter of this year, with further outcomes of PK and safety at the delivery time anticipated in the third quarter.
Taking place at sites across Europe, the trial will enrol subjects in three stages, starting with a sentinel pregnant woman, followed by two cohorts with a total enrolment target of eight subjects.
Its secondary objectives include evaluations of pregnancy and neonatal/infant findings, as well as monitoring for the emergence of HPA-1a alloimmunisation.
A data review for subjects and infants is due to be carried out before the start of each cohort.
Rallybio CEO Stephen Uden said: “Dosing the sentinel participant in our RLYB212 Phase II trial marks a significant milestone for our RLYB212 programme and for Rallybio.
“We plan to provide an update in the second quarter, as we continue to advance our mission to deliver a safe and effective therapeutic to prevent maternal alloimmunisation and the potentially catastrophic consequences of FNAIT.”
RLYB212 is a monoclonal antibody designed to prevent maternal alloimmunisation by rapidly eliminating HPA-1a positive foetal platelets from the mother's circulation.
By preventing the mother's immune system from becoming sensitised to the foetal platelets, the drug aims to eliminate the risk of FNAIT, a rare but potentially life-threatening condition that can cause severe bleeding in foetuses and newborns.
In September 2023, Rallybio reported outcomes from a Phase I first-in-human clinical trial of its drug candidate RLYB116, which is designed to treat complement-mediated diseases.
"Rallybio doses first subject in Phase II trial of treatment for FNAIT in Europe" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.
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