The most important finding in this first phase 2 study is that the unique candidate drug BVT.115959 is very safe and tolerable. Moreover, a positive treatment effect that increased over time was observed although the analysis of the primary variable was not statistically significant. Further analysis of the efficacy data showed statistical significance. The conclusion of these observations is that BVT.115959 has a clear opportunity to show good efficacy and few side-effects in further studies.
192 patients with chronic neuropathic pain secondary to diabetes were included in this exploratory phase 2 study. The study is the first of its kind with a compound which is steered to its target protein (A2A-receptor) depending upon pH in the injury area... Biovitrum's Press Release -