Paris-based Neovacs got hammered yesterday after the biotech spread the word that its Phase IIb study of an experimental therapeutic vaccine for rheumatoid arthritis flopped.
Shares of the biotech (Alternext Paris: $ALNEV) dropped by more than half after investigators noted that the 140-patient study of its lead therapy, TNF-Kinoid, had failed to hit either of its two primary endpoints on efficacy. The drug is designed to marshal an army of anti-TNF antibodies, but investigators said it appeared that the treatment did not generate the expected force of neutralizing antibodies needed to improve symptoms of the disease.
TNF-Kinoid is also being studied for Crohn's disease.
"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," CEO Miguel Sieler said in a statement. "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."
In the meantime, Sieler said that the company will shift focus to its other clinical-stage program for IFNα-Kinoid, another immunotherapy being studied for lupus. The biotech said it has enough cash on hand "until Q2 2015," which is just months away, with the runway being extended by a €20 million financing deal with Kepler Cheuvreux.
- here's the release