Biocon & Equillium: Phase 2 Itolizumab Ulcerative Colitis Trial Results

Biocon Limited and Equillium Inc. have announced encouraging results from a Phase 2 clinical trial assessing Itolizumab, a novel monoclonal antibody, for the treatment of moderate to severe ulcerative colitis (UC). The trial, which compared Itolizumab with adalimumab (a standard treatment) and a placebo, demonstrated higher remission rates and positive safety outcomes.

Trial Overview

The double-blind, placebo-controlled study enrolled 90 biologic-naïve patients with moderate to severe ulcerative colitis. Participants were randomised into three groups:

1. Itolizumab (140 mg every two weeks)
2. Adalimumab, a globally recognised biologic treatment
3. Placebo

The primary goal was to evaluate clinical remission rates after 12 weeks, using the Total Mayo Score, a widely accepted measure for ulcerative colitis severity. The trial was conducted across multiple sites in India and was designed with input from leading gastroenterology experts.

Key Findings

• Clinical Remission: 23.3% of patients receiving Itolizumab achieved clinical remission, compared to 20% with Adalimumab and 10% with the placebo.
• Clinical Response: 63.3% of patients on Itolizumab experienced clinical response, compared to 60% with Adalimumab and 46.7% with the placebo.
• Endoscopic Remission: Itolizumab and Adalimumab both achieved 16.7% endoscopic remission, compared to 6.7% for the placebo.
• Safety Profile: The treatment was well tolerated, with no significant safety concerns reported.

Understanding Itolizumab’s Mechanism

Itolizumab is a monoclonal antibody targeting the CD6-ALCAM signalling pathway, which plays a crucial role in T-cell activity and immune response. By selectively modulating T-effector cells while preserving regulatory T-cells, the drug has shown potential to control inflammation in autoimmune diseases.

What’s Next?

Biocon and Equillium plan to present detailed findings at upcoming medical conferences in 2025. The companies will also evaluate potential Phase 3 trials for ulcerative colitis as they continue to explore the broader implications of Itolizumab in autoimmune disorders.

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