Forte Biosciences Announces Positive Data in FB102 Celiac Disease Phase 1B Study

About this update from Forte Biosciences, Inc.

[{"type":"text","content":"Phase 2 Celiac Disease Trial Initiating with Topline Readout Expected in 2026","length":77,"tagName":"p","attribs":{}},{"type":"text","content":"Forte will be Hosting a Conference Call to Discuss the Results at 8:30 am ET","length":76,"tagName":"p","attribs":{}},{"type":"text","content":"DALLAS, June 23, 2025--(BUSINESS WIRE)--Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced positive data from a Phase 1b trial in celiac disease for lead program FB102 (FB102-101).","length":304,"tagName":"p"},{"type":"text","content":"The company will be hosting a conference call today at 8:30 am ET. Prof. Jason Tye-Din, Head of Celiac Research at the Walter and Eliza Hall Institute and principal investigator in the FB102-101 study will be participating in the call.","length":235,"tagName":"p"},{"type":"text","content":"Please connect to the call using the following link: https://lifescievents.com/event/jgs927tsivn4w038/. The event and accompanying slides can also be accessed by visiting the investor relations section of the company's website at https://www.fortebiorx.com/investor-relations/default.aspx. An archived webcast will be available on the company's website following the event.","length":381,"tagName":"p"},{"type":"text","content":"The FB102-101 Phase 1b celiac disease study enrolled 32 subjects 3:1 randomized (24 on FB102 and 8 on placebo). Subjects received 4 doses of FB102 (10 mg/kg) and underwent a 16 day gluten challenge. In addition to safety and tolerability, the study assessed morphologic and inflammatory endpoints along with gluten challenge (GC) induced symptoms.","length":347,"tagName":"p"},{"type":"text","content":"FB102 demonstrated a statistically significant benefit on the composite histological VCIEL endpoint (change from baseline). The mean VCIEL change from baseline was -1.849 for placebo subjects compared to 0.079 for FB102 treated subjects (p=0.0099).","length":248,"tagName":"p"},{"type":"text","content":"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 (p=0.0035). Baseline IEL density was 25.6 for the placebo subjects and 23.5 for the FB102 treated subjects.","l...

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