Rallybio has received approval to begin testing a preventive treatment for a rare but serious pregnancy complication that affects mothers and their unborn babies. The condition, known as fetal and neonatal alloimmune thrombocytopenia (FNAIT), occurs when a pregnant woman’s immune system attacks her baby’s platelets, potentially causing dangerous bleeding in the fetus or newborn.
The company will begin Phase 2 clinical trials of their drug RLYB212 after receiving approvals from both European and UK health authorities. This represents the first time a preventive treatment for FNAIT will be tested in pregnant women at high risk for developing this condition.
“Securing these CTA approvals from European health authorities to advance RLYB212 into a Phase 2 clinical trial is a significant achievement. 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,” said Stephen Uden, M.D., Chief Executive Officer of Rallybio. “We are activating clinical sites and expect to initiate screening this quarter, which will mark another important step toward achieving our mission to prevent FNAIT and its potentially devastating consequences.”
The trial will take place across five European countries – Belgium, the Netherlands, Norway, Sweden, and the UK. Eight pregnant women at higher risk for FNAIT will receive the treatment, which is an antibody designed to prevent the mother’s immune system from developing a response against the baby’s platelets. The treatment will begin at week 16 of pregnancy and continue with monthly doses until delivery.
“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,” said Steven Ryder, M.D., Chief Medical Officer at Rallybio. “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.”
The development is particularly significant because currently there is no approved treatment to prevent or treat FNAIT during pregnancy. Recent research by Rallybio has shown that this condition threatens more pregnancies than previously thought – over 30,000 pregnancies are at risk each year, with rates 40% higher in diverse populations than earlier estimates suggested.
Alongside this trial, Rallybio is also conducting a study to better understand how FNAIT affects different populations, information that will be crucial for their larger Phase 3 trial planned for the future.
