Rallybio (RLYB) announced the discontinuation of the RLYB212 program for the prevention of fetal and neonatal alloimmune thrombocytopenia. The decision was based on pharmacokinetic data from the Phase 2 clinical trial demonstrating the inability of the RLYB212 dose regimen to achieve predicted target concentrations, as well as the minimum target concentration required for efficacy.
Rallybio said it remains focused on advancing RLYB116, a once-weekly low volume C5 inhibitor for the treatment of complement-driven diseases, as well as its emerging preclinical programs.
Stephen Uden, CEO of Rallybio, said: "Given that the results significantly deviated from the predicted range and the absence of empiric data to further inform dose adjustment, the risk/benefit no longer supports continued dosing, and we will discontinue RLYB212 development."
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