TNF-Kinoid: Interim Phase II data

Neovacs said it will not enroll a second cohort of patients in the double-blind, international Phase II TNF-K-005 trial after interim data from the first cohort of 60 patients with moderate to severe CD who have failed >=1 anti-TNF therapy showed that 3 doses of 180 µg TNF-Kinoid did not significantly improve clinical remission rates, the primary endpoint, vs. placebo. The company did say that there was a significant correlation between the proportion of patients achieving clinical remission and the highest levels of anti-TNF antibodies induced by TNF-Kinoid. However, according to Neovacs, an unexpectedly high proportion of patients had residual anti-TNF mAb levels at baseline despite a washout period of several weeks, which the company believes may have had a negative effect on the immune response and efficacy of TNF-Kinoid. ...