Rallybio has announced the initiation of a Phase 2 clinical trial for RLYB212, a novel preventive treatment for fetal and neonatal alloimmune thrombocytopenia (FNAIT). This trial marks a significant step forward in addressing a rare but serious pregnancy complication that can lead to dangerous bleeding in the fetus or newborn. Approvals have been secured from European and UK health authorities, paving the way for the first preventive FNAIT treatment to be tested in pregnant women at high risk.
Trial Design and Objectives
The Phase 2 trial will be conducted across five European countries: Belgium, the Netherlands, Norway, Sweden, and the UK. Eight pregnant women identified as being at higher risk for FNAIT will participate. The treatment regimen involves administering RLYB212, an antibody designed to prevent the mother's immune system from developing a response against the baby's platelets, beginning at week 16 of pregnancy and continuing with monthly doses until delivery.
The primary objective of the trial is to assess the safety and efficacy of RLYB212 in preventing maternal alloimmunization, a key factor in the development of FNAIT. Secondary endpoints will include monitoring the incidence of FNAIT in newborns and evaluating the overall health outcomes for both mothers and infants.
Addressing an Unmet Need
Currently, there is no approved treatment to prevent or treat FNAIT during pregnancy, leaving clinicians with limited options for managing this condition. FNAIT occurs when a pregnant woman's immune system attacks her baby's platelets, potentially causing severe bleeding complications. Recent research by Rallybio indicates that FNAIT may threaten more pregnancies than previously estimated, with over 30,000 pregnancies at risk each year and rates 40% higher in diverse populations compared to earlier estimates.
Management Perspective
"Securing these CTA approvals from European health authorities to advance RLYB212 into a Phase 2 clinical trial is a significant achievement," said Stephen Uden, M.D., Chief Executive Officer of Rallybio. "These approvals are a testament to the dedication and innovation of our team and our partners as we advance this first ever program to prevent maternal alloimmunization and FNAIT."
Steven Ryder, M.D., Chief Medical Officer at Rallybio, added, "These approvals recognize Rallybio’s commitment to safely and effectively progress a novel prophylactic approach for preventing alloimmunization in pregnant women at higher FNAIT risk. We are proud to be leaders in bringing much needed innovation to this area of women’s health, which has gone unaddressed for far too long."
Further Research
In addition to the Phase 2 trial, Rallybio is also conducting a study to gain a better understanding of how FNAIT affects different populations. The information gathered from this study will be crucial for the design and execution of a larger Phase 3 trial planned for the future.
