- Rallybio Corporation RLYB says clinical proof-of-concept has been achieved in Phase 1b study for RLYB212 for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT).
- Results show that RLYB212 could rapidly and completely eliminate transfused HPA-1a positive platelets in HPA-1a negative subjects one week after a single subcutaneous dose.
- The reduction in mean platelet elimination half-life was greater than 90% in both RLYB212 dose groups compared to placebo and was dose-related.
- The broad range of pharmacokinetic and pharmacodynamic data allows substantive modeling to inform dose selection for a future registrational study.
- RLYB212 was observed to be well-tolerated, with no serious adverse events reported.
- The company expects to report data from the Phase 1b clinical study of RLYB212 at a scientific conference in 2023.
- Rallybio also announced that testing in the multi-dose cohort of its single-center Phase 1 trial in Europe began in the first quarter of 2023 to evaluate the safety and pharmacokinetics of RLYB212 based on repeat dosing over 12 weeks in healthy male and female participants.
- The company expects results in Q4 of 2023.
- The company also announced that RLYB211, a plasma-derived polyclonal anti-HPA-1a antibody, will not be advanced further in clinical development.
- Cash Position: As of Dec. 31, 2022, cash, cash equivalents, and marketable securities were $169.0 million.
- Price Action: RLYB shares are up 15.89% at $9.19 on the last check Monday.
- Photo Via Company
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