Paion has announced that it will change the start-date of its study of the drug candidate Solulin. The company has received detailed feedback from German authority BfArM (Federal Institute for Drugs and Medical Devices) on their clinical trial application), which will require the generation of additional data.
In its response, BfArM has requested additional data mainly regarding pre-clinical and production related issues. The company has initiated the necessary programme and will resubmit as soon as the data are available. Under the revised schedule the first Phase I study with this recombinant human soluble thrombomodulin is now anticipated for Q4 2006 instead of mid-year as originally scheduled.
The planned first-into-man Phase I study aims at exploring safety and tolerability and pharmacokinetics with various intravenous doses of Solulin administered to healthy volunteers. The company plans to develop Solulin for the treatment stroke but is also evaluating other cardiovascular indications.