Finland-based biopharmaceutical firm Faron Pharmaceuticals has received recommendation from the Independent Data Monitoring Committee (IDMC) to continue its Phase III clinical trial (INTEREST) of Traumakine (FP-1201-lyo) to treat moderate-to-severe acute respiratory distress syndrome (ARDS).
Based on recombinant human intra-venous interferon beta (IFN beta-1a), Traumakine is being developed to prevent vascular beds leakage in acute lung injuries.
The double-blind, randomised, parallel-group Phase III INTEREST trial will evaluate the efficacy and safety of Traumakine compared to placebo.
Being performed at 60 hospital intensive care units (ICU) in Belgium, Finland, France, Germany, Italy, Spain and the UK, the trial is expected to conclude enrolment of 300 subjects in the fourth quarter of this year.
The primary efficacy endpoint of the trial is all-cause mortality rate at day 28, with a trial protocol target of 50% decrease in all cause mortality at day 28 between placebo and treatment arm.
Following the completion of patient recruitment, the firm intends to initiate an expanded access programme to allow use of Traumakine for eligible patients at ICU hospitals in Europe before the regulatory approval.
Faron Pharmaceuticals CEO Dr Markku Jalkanen said: “Given this imminent completion, and based on the potential benefits that Traumakine could offer, further supported by another successful safety review, we plan to set up a compassionate use programme for named patients with this severe disease following closure of the trial.
“The aim of this programme is to provide continued access to Traumakine once the INTEREST trial sites close, until conclusion of the regulatory approval process.”
Image: Chest X-ray of a patient with ARDS. Photo: courtesy of Samir/Wikipedia.