Biovitrum has completed a first phase 2 study in patients with neuropathic pain. The candidate drug, BVT.115959, is a pH-selective A2A-receptor agonist for the treatment of pain. The results of this first patient study is promising as it shows a high level of safety and tolerability, as well as a positive treatment effect that increased over time.
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.
BVT.115959 decreases inflammation by activating the adenosine receptor 2A in injured tissue. As a consequence of this, 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.
“Patients with chronic neuropathic pain are in great need of improved treatment options. Also, there is a great commercial potential in this area. Consequently, the promising observations in this first phase 2 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”, says Biovitrum’s CEO Martin Nicklasson.
For more information please contact:
Biovitrum AB (publ) Erik Kinnman, Vice President Investor Relations Phone: +46 73 422 15 40 erik.kinnman@biovitrum.com
Martin Nicklasson, CEO Phone. +46 8 697 20 00 martin.nicklasson@biovitrum.com
