Rallybio, a New Haven-based biotechnology firm, said Tuesday it has discontinued development of a therapy intended to prevent a rare immune disorder in fetuses and newborns.
The firm’s RLYB212 program was intended to prevent fetal and neonatal alloimmune thrombocytopenia, or FNAIT. The decision to discontinue developing RLYB212 was based on data from a Phase 2 clinical trial that demonstrated 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.
The company is developing therapies to address rare diseases in the areas of hematology, immuno-inflammation, maternal fetal health, ophthalmology and metabolic disorders.
“We are disappointed by the PK results of the RLYB212 Phase 2 trial,” said Dr. Stephen Uden, Rallybio CEO. “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.”
The decision comes as Rallybio faces being delisted from the Nasdaq Stock Market. Its stock opened at 25 cents per share Tuesday morning.
