Neovacs' Phase IIb study of TNF-Kinoid in rheumatoid arthritis fails to meet primary endpoints

French autoimmune specialist Neovacs (Alternext Paris: ALNEV) says that its Phase IIb trial of TNF-Kinoid in rheumatoid arthritis failed to meet primary endpoints.

Although the trial confirmed the safety, tolerability and immunogenicity of TNF-Kinoid, it did not meet its primary endpoints and further evaluation is ongoing.

All patients in the trial except one showed significant immune response, producing anti-TNF binding antibodies. The patients, however, did not produce neutralizing antibodies, which is the most likely hypothesis to explain the absence of a statistically significant clinical response. Neovacs intends to further analyze these top line data to determine the reason for the absence of a significant clinical response.

Miguel Sieler, chief executive of biotech firm Neovacs, said: "We are disappointed that our TNF-Kinoid Phase IIb study did not have a positive outcome, given the potential benefits that this new approach would have brought to patients suffering from RA. We are in the process of analyzing the data in depth to understand the lack of clinical efficacy for TNF-Kinoid in this trial and to discuss potential next steps with Neovacs Scientific Advisory Board and with our prospective partners. These findings will determine future developments of TNF-Kinoid within our portfolio.”