The most important finding in this first Phase II 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 potential to fulfil a great medical need to treat chronic pain without giving rise to central nervous system derived side effects.
Approximately 192 patients with chronic neuropathic pain secondary to diabetes were included in this exploratory Phase II study. The study is sid to be the first of its kind with a compound which is steered to its target protein (A2A-receptor) depending upon pH in the injury area.
Martin Nicklasson, CEO of Biovitrum, said: “Patients with chronic neuropathic pain are in great need of improved treatment options. Consequently, the promising observations in this first Phase II study with a new and safe treatment option for pain is good news. Our plan is to out-license the project in line with our business strategy.”