Paion reports positive results of anticoagulant study

In the study, five groups of volunteers were each administered a single dose of Solulin, with escalating dosages in the consecutive dose groups. Each dose increase was first approved by the study safety committee. As a reference, some of the study subjects received a pharmacologically inactive substance, a placebo.

Within the chosen dose range of 0.6 to 30mg, Solulin was shown to inhibit thrombin formation in a dose-dependent manner by up to 98%. Already in the lowest dose group an effect could be seen and a 50% inhibition of thrombin formation was achieved with 1mg. The factor 50 between the lowest and the highest dose of Solulin confirms the good tolerability of the substance already seen in the preclinical studies. In addition, the results indicate a long elimination half-life for Solulin which may allow for longer treatment intervals in a future therapeutic application. After the completion of the single-dose tests, multiple-dose schedules are now being tested in healthy volunteers.

Mariola Sohngen, chief medical officer of Paion, said: “Solulin was safe and well tolerated over a broad dose range. Exploring the administration of Solulin to healthy volunteers over five consecutive days, which has been started already, will give us more information on an optimal treatment scheme for a first clinical study in patients suffering from thrombotic diseases.”