Forte Biosciences has announced promising results from its Phase 1b clinical trial of FB102, a new investigational therapy for celiac disease.

Trial Overview

The FB102-101 study enrolled 32 participants, randomised 3:1 to receive either FB102 or placebo. Throughout the trial, participants received four doses of the drug and underwent a 16-day gluten challenge.

Key Findings

• Histological Improvement: FB102 significantly improved the composite VCIEL score, a measure of intestinal damage.

• Immune Cell Reduction: CD3+ intraepithelial lymphocytes (IELs) increased by 13.3 in the placebo but decreased by 1.5 in the FB102 group.

• Vh:Cd Ratio ( a measure of small intestinal health) : FB102 showed a 73% improvement over placebo in preserving villus-to-crypt architecture.

• Symptom Relief: Participants receiving FB102 reported a 42% reduction in gluten-induced GI symptoms.

• Safety: No severe adverse events (SAEs); all reported side effects were mild. No dropouts occurred.

Why It Matters

FB102 may represent a potential treatment for celiac disease that protects against gluten-induced damage, without requiring a strict gluten-free diet. While in the early stages, the results show strong promise in both gut healing and symptom relief.

The Bottom Line

FB102 is still in development, but this trial suggests it may offer a safe and effective therapeutic option for people with celiac disease. Further trials will be needed to confirm its benefit in larger, longer-term studies.

You can read more about this here: https://finance.yahoo.com/news/forte-biosciences-announces-data-trial-170606495.html?guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAAJa8T2MHQCHP9_-DDhGcZ2aJUShfIKbUijr7vUI5-Zp2dYT3n8e_XcDvoecDXcAxFHryn7YwfPs7g10QXeZ_n1VNIJqJDaob_ii8AksyH2yXDZScchdB5Ov49CoZCD9gANfExe0J79s8lLJ4hT3qGeVi4x7Kc-vADDUbRf4JB0M&guccounter=2