By Robb M. Stewart
Rallybio has dropped its development program on a prevention for a rare immune disorder that occurs in pregnancy, though a trial of its lead program is on track.
The clinical-stage biotechnology company said Tuesday it discontinued its RLYB212 program following disappointing results in a Phase 2 trial. Pharmacokinetic data demonstrated an inability of the RLYB212 dose regimen to achieve predicted target concentrations, as well as the minimum target concentration required for efficacy, it said.
The single-arm Phase 2 dose confirmation trial was designed to assess the pharmacokinetic and safety of RLYB212 in pregnant women at higher risk for alloimmunization and fetal and neonatal alloimmune thrombocytopenia, or FNAIT.
FNAIT is a rare immune disorder that occurs when the baby's platelets are attacked and destroyed by the mother's immune cells in her blood stream.
"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," Chief Executive Stephen Uden said.
Rally bio 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 said it remains on track to initiate dosing in the RLYB116 confirmatory clinical pharmacokinetic-pharmacodynamic study in the second quarter of 2025, with data readouts from Cohorts 1 and 2 expected in the third and fourth quarter, respectively.
Rallybio's shares were halted ahead of the news. The stock last closed at $0.42, down 56% so far this year.
Write to Robb M. Stewart at robb.stewart@wsj.com
(END) Dow Jones Newswires
April 08, 2025 08:42 ET (12:42 GMT)
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