Jun. 23 at 11:41 AM
$FBRX Forte Biosciences announces data from trial in celiac disease for FB102
orte Biosciences announced data from a Phase 1b trial in celiac disease for lead program FB102. The FB102-101 Phase 1b celiac disease study enrolled 32 subjects 3:1 randomized. Subjects received 4 doses of FB102 and underwent a 16-day gluten challenge. In addition to safety and tolerability, the study assessed morphologic and inflammatory endpoints along with gluten challenge induced symptoms. FB102 demonstrated a statistically significant benefit on the composite histological VCIEL endpoint.
The mean VCIEL change from baseline was -1.849 for placebo subjects compared to 0.079 for FB102 treated subjects. The change in the density of CD3-positive T cells, or IELs, from baseline was an increase of 13.3 for placebo subjects compared to a decline of 1.5 for FB102 treated subjects. Baseline IEL density was 25.6 for the placebo subjects and 23.5 for the FB102 treated subjects. The mean change in the Vh:Cd ratio from baseline was -0.173 for placebo subjects compared to -0.046, a 73% improvement for FB102 treated subjects compared to placebo.
Gluten challenge induced GI symptoms reported during the 16-day gluten challenge from patient diaries/AE collection demonstrated a 42% benefit for FB102 treated subject. There were no dropouts in the study. Treatment emergent adverse events were primarily mild with no grade 3 or higher SAEs reported in the FB102 arm.
