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Rallybio Announces Results of Epidemiological Analysis Demonstrating FNAIT Risk Across Racially and Ethnically Diverse Populations
– First Reported Large-Scale Analysis of FNAIT Risk Across Broad Population of Diverse Ancestries – – Topline Results Suggest a Significant Increase in the
About this update from Rallybio Corporation
[{"type":"text","content":"\n– First Reported Large-Scale Analysis of FNAIT Risk Across Broad Population of Diverse Ancestries –\n\n\n– Topline Results Suggest a Significant Increase in the Number of Pregnancies at Higher Risk for FNAIT Annually and the RLYB212 Addressable Market –\n\n\n– Rallybio On Track to Initiate RLYB212 Phase 2 Dose Confirmation Study in Pregnant Women at Higher Risk for FNAIT in 2H 2024 –\n\n\n NEW HAVEN, Conn.--(BUSINESS WIRE)--\nRallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today reported topline results from an epidemiological analysis of large genomic datasets evaluating the frequency of fetal and neonatal alloimmune thrombocytopenia (FNAIT) risk in diverse ancestries. Data from this analysis confirmed Caucasian populations as having the greatest proportion of women with the genetic markers for higher FNAIT risk (HPA-1a negative, HLA-DRB3*01:01 positive). Additionally, data from this analysis provides, for the first time, robust evidence quantifying the proportion of women in non-Caucasian ancestries that carry the genetic markers for higher FNAIT risk.\n\n\nThese data indicate that the proportion of pregnant women at higher risk for FNAIT annually has been significantly underestimated. For example, in key geographies of North America and major European countries, it is estimated that more than 30,000 pregnancies each year are at higher risk for FNAIT, representing a 40% increase from prior estimates. Full data from the epidemiological analysis are expected to be presented at a scientific conference in the fourth quarter of 2024.\n\n\n“This epidemiological analysis leverages the availability of large-scale, diverse genomic datasets, and provides the first clear evidence of the extent to which ancestries beyond the Caucasian population can carry a higher risk for FNAIT,” said Stephen Uden, MD, Chief Executive Officer of Rallybio. “These data indicate that FNAIT risk is more prevalent than previously estimated and highlights the importance of screening. Unlike many other rare diseases, we believe that screening for FNAIT risk could be seamlessly incorporated into standard prenatal care for all mothers. This would ensure all women at higher risk for FNAIT could then be offered prophylactic treatm...