Neovacs initiates a Phase II clinical study of its TNF‐Kinoid in Crohn’s Disease Patients
Neovacs announced the start of a Phase 2 international clinical trial to study the efficacy of the TNF‐Kinoid in patients suffering from Crohn’s Disease.
Consistent with the indications in the Company’s announcement of 8th December 2010, at the end of December, Neovacs received consents from the regulatory authorities and ethics committees in both France and Belgium, allowing the start of patient recruitment for this study. The double‐blind, randomized, placebo‐controlled TNF‐K‐005 study will recruit between 66 and 132 patients with moderate to severe Crohn’s Disease (having a Crohn’s Disease Activity Index, CDAI, of between 220 and 450) and who have failed treatment with a TNF inhibitor. The primary endpoint of the study is to measure the efficacy of the TNF‐Kinoid in inducing clinical remission, defined as a CDAI of 150 or less. Other measures of clinical activity to be measured include clinical response, defined as a decline in CDAI of 100 points or more as compared to the value at study entry, mucosal healing measured by colonoscopy, and relevant biomarkers.
Final top‐line results of the prior clinical study, TNF‐K‐001 were announced on 8th December. This study demonstrated a good safety profile for the TNF‐Kinoid and that the 180mcg and 360mcg produced an antibody response to the TNF cytokine in patients. Further, a high rate of clinical response was observed, with nearly half the patients achieving clinical remission.
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