– Results Indicate that FNAIT Risk is More Prevalent Than Previously Estimated –
NEW HAVEN, Conn.--(BUSINESS WIRE)-- Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, announced today that full data from an epidemiological analysis quantifying the proportion of women across diverse populations at higher risk of a fetal and neonatal alloimmune thrombocytopenia (FNAIT)-impacted pregnancy will be presented at the American Society of Human Genetics (ASHG) 2024 Annual Meeting to be held November 5 – 9, 2024 in Denver, CO.
“With our Phase 2 trial of RLYB212 in pregnant women at higher risk for HPA-1a alloimmunization and FNAIT on track to initiate in the fourth quarter of 2024, we continue our efforts to raise awareness of FNAIT and broaden the understanding of the population at risk for this potentially devastating disease,” said Stephen Uden, MD, Chief Executive Officer of Rallybio. Dr. Uden continued, “Data from this analysis provide the first clear evidence of the extent to which ancestries beyond the Caucasian population can carry a higher risk for FNAIT, underscoring the importance of screening all pregnant women for FNAIT risk as part of standard prenatal care. This would ensure that all women at higher risk for FNAIT could then be offered prophylactic treatment with RLYB212, if approved.”
The ASHG abstract #7041T, which can be found here, details the high-level findings of the epidemiological analysis. In this analysis, women at higher risk for alloimmunization and FNAIT were defined as those having an HPA-1a negative and HLA-DRB3*01:01 positive genotype. Allele frequencies were obtained from gnomAD v4 for HPA-1a and the U.S. National Marrow Donor Registry (NMDR) for HLA-DRB3*01:01.
Proportions of women at risk of alloimmunizing were highest in Caucasian populations, with the highest proportions in the Ashkenazi Jewish population (2.36% and 0.65% of women at risk and at higher risk, respectively), followed by non-Finnish Europeans (2.34% and 0.64%), Middle Eastern (2.25% and 0.62%), Amish (2.25% and 0.62%), White Hispanic (2.25% and 0.59%) and Finnish (2.03% and 0.56%). Additionally, women in some non-Caucasian population groups were also found to be at risk including the Caribbean Hispanic population (1.48% and 0.33%), followed by African / African American (1.13% and 0.28%). Women of South Asian, East Asian and Amerindigenous ancestries were found to have lower risk (