Finland-based clinical stage biopharmaceutical firm Faron Pharmaceuticals has commenced enrolment in the Phase II INFORAAA clinical trial of traumakine (FP-1201-lyo) to treat patients with multi-organ failure (MOF) in ruptured abdominal aorta aneurysm (RAAA).
Traumakine is a recombinant human IFN beta-1a based on a patent-protected use of interferon beta to prevent leakage of vascular beds in acute lung injuries.
It increases the lung CD73 expression and production of anti-inflammatory adenosine to decrease vascular leaking and inflammation.
The double-blind, randomised, parallel group Phase II trial will evaluate the efficacy and safety of the drug in preventing MOF following open surgery for RAAA.
Faron chief executive officer Markku Jalkanen said: "We believe that Traumakine shows significant efficacy for the recovery of operated RAAA patients.
"Furthermore, there is a possibility that a positive outcome of both the INFORAAA and INTEREST trials could result in the INFORAAA trial fulfilling Phase III trial requirements.
"The clinical data of RAAA patients treated with FP-1201-lyo during the INFORAAA trial could also provide us with valuable information on the recovery of ischemic single organ injuries and planning further trials to treat these injuries.”
The INFORAAA trial will determine mortality after 30 days of the first dose administration as the primary endpoint, along with multiple secondary and explorative endpoints.
It is currently initiated with eight sites in the country and the firm intends to expand the trial to Baltic States and the UK.
The drug is being currently investigated in a European Phase III clinical trial (INTEREST) for the treatment of acute respiratory distress syndrome (ARDS) patients who also experience MOF.