Registro de fonte primária
A coorte de desafio com glúten da Fase 1b cumpriu todos os principais endpoints histológicos e de sintomas com proteção estatisticamente significativa e clinicamente relevante versus placebo (Vh:Cd LS-mean change -0.17 vs -0.66; IEL density -1.20 vs +18.83). O ANB033 foi bem tolerado, sem SAEs ou descontinuações de tratamento devido a AEs. A empresa planeia avançar o ANB033 para o desenvolvimento de fase avançada na doença celíaca em 2027, após discussões regulatórias.
EX-99.1 2 trax-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 EX-99.2 3 trax-ex99_2.htm EX-99.2 EX-99.2 Exhibit 99.2 First Tracks Biotherapeutics Announces Positive Top-Line Results for ANB033 in Gluten-Challenge Study in Celiac Disease • ANB033 achieved a statistically significant and clinically meaningful protective effect on both gluten-induced intestinal damage and symptoms • LS mean change from baseline in Vh:Cd ratio of -0.17 on ANB033 vs. -0.66 on placebo, a +0.49 placebo-adjusted delta ( p =0.009) • LS mean change from baseline in IEL density of -1.20 on ANB033 vs. +18.83 on placebo, a -20.03 placebo-adjusted delta ( p <0.001) • Prevented an increase in symptoms throughout the entire gluten challenge, with lower CDSD score on ANB033 vs. placebo that was statistically significant