Biospace has reported data from a 28 week interim analysis of  the 52 week phase III TREAT-PLAQ study of itolizumab, a humanised anti CD-6 monoclonal antibody, in patients with moderate to severe chronic plaque psoriasis.

The 52 week study conducted in India had a 12 week placebo controlled phase, 16 week consolidation and 24 week randomised withdrawal phase and enrolled over 200 patients across placebo and two active treatment regimens. The primary endpoint was defined as a significant improvement in PASI-75 (Psoriasis Area and Severity Index) score after 12 weeks of treatment compared to placebo.

The interim analysis, found that both treatment regimens were statistically significantly better than placebo with the fixed dose regimen of 1.6 mg/kg every two weeks for 12 weeks followed by 1.6 mg/kg every 4 weeks for 16 weeks demonstrating a response rate of 36% (p<0.0043) at Week 12 and 46% at Week 28. The response rates for patients with PASI> 20 at baseline was 43% and 54% at Week 12 and 28 respectively.

The analysis also reported rates of infection of approximately 10%, in the treatment arms.

Biocon plans on presenting the safety and efficacy data from the entire 52 week study at an upcoming scientific meeting.