NEOVACS announces top-line phase IIb clinical trial results of TNF-Kinoid in Rheumatoid Arthritis
NEOVACS announced top line data on the Phase IIb clinical trial of TNF-Kinoid in rheumatoid arthritis (RA). This trial confirmed the immunogenicity and good tolerance of TNF-Kinoid with no safety issues, but did not meet its primary efficacy endpoint.
"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," said Miguel Sieler, Neovacs CEO.
"As we analyze these data, we will focus our research efforts and resources on the clinical development of IFNα-Kinoid in lupus, a disease that affects over six million people worldwide, and for which no fully effective biological treatment currently exists."
TNF-Kinoid Phase IIb trial in Rheumatoid Arthritis fails to meet primary endpoint
In 2014, Neovacs completed a randomized, double-blind, placebo-controlled, multicenter 140-patients Phase IIb clinical trial of TNF-Kinoid in RA. The co-primary endpoints for the study were based on the DAS28-CRP and ACR 20 scores - measures commonly used in clinical trials for RA.
The study confirmed the safety and tolerability of the product. An independent Data Safety and Monitoring Board had previously issued positive assessments on safety in January and March 2014.
All patients, except one, showed a significant immune response, producing anti-TNF binding antibodies.
However, the patients 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 s top line data to determine the reason for the absence of a significant clinical response.
"The findings of the TNF-Kinoid study in RA and our continued work with this program have allowed us to make significant progress on our understanding of active immunotherapies for the treatment of auto-immune diseases. The clinical results of this study do not preclude further development of the Kinoid platform, in particular IFNα-Kinoid in lupus. Neovacs' program in lupus is highly promising from a scientific perspective, based on the existing clinical and preclinical findings which show strong immune response with neutralizing antibodies, as well as an improvement of lupus related biomarkers," said Professor Jacques Banchereau, Ph.D, chairman of Neovacs' scientific advisory board.
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