Encouraging results from the Phase I/II clinical trial of TNF-Kinoid in Crohn's Disease
Neovacs announced the final results of its Phase I/II clinical trial of TNF-Kinoid which showed the drug candidate's excellent safety profile in all subjects, an immune response to the drug as intended, and a high clinical response rate, with clinical remission (absence of symptoms) in almost half the patients.
The TNF-K-001 Phase I/IIa clinical trial was performed in 21 patients suffering from moderate to severe Crohn's disease (defined as a Crohn’s Disease Activity Index (CDAI) of between 220 and 400). Each patient received three administrations of one of three dose levels of TNF-Kinoid (60 mcg, 180 mcg or 360 mcg) on days 0, 7 and 28, with four patients also receiving a maintenance dose at month 6. The study's primary objective was to assess TNF-Kinoid's safety and its ability to induce an immune response to tumor necrosis factor (TNF). The final results presented today confirm the drug candidate's excellent safety profile; no treatment-related serious adverse events, unusual infections or premature study withdrawals were recorded. Reactions to administration of the Kinoid (whether local or systemic) were mild, transient and limited to a few patients.
In terms of immune response, in 17 of the 21 treated patients, TNF-Kinoid induced the production of anti-TNF antibodies. Of the three patients receiving the lowest dose (60 mcg), only one mounted an immune response to TNF. In both the 180 and 360 mcg dose levels, 8 of the 9 patients in each group (89%) produced anti-TNF antibodies.
In terms of clinical response (at study week 12 and after 3 administrations of the drug), 76% of the patients showed a significant clinical improvement (defined as a 70-point drop in the CDAI) and 43% of these patients were in clinical remission (i.e. the absence of symptoms, as evidenced by a CDAI at or below 150).
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