Endothelial barrier is everything BRIEFLY IN FINNISH ABOUT US DRUG TARGETS PIPELINE NEWS INVESTOR RELATIONS CONTACT Pipeline HomePipelineTraumakine Clinical Programme Traumakine® Clinical Programme The Traumakine® clinical programme addresses the treatment of Acute Respiratory Distress Syndrome (ARDS), which is a life threatening condition. ARDS is an orphan lung disease with no available drug treatment. The scientific rationale for Traumakine treatment is based on the use of interferon-beta for the restoration of the endothelial barrier function in ARDS patients. Read more about Traumakine® Phase I/II trial completed successfully The first clinical trial in the Traumakine programme was a Phase I/II open-label study to assess the safety, tolerability and preliminary efficacy of interferon-beta in the treatment of patients with ARDS. This study consisted of dose escalation (Phase I) and dose expansion (Phase II) phases. In the dose escalation phase, four interferon-beta levels were tested. The dose expansion phase was conducted using the optimal tolerated dose. A total of 37 ARDS patients were treated at nine hospitals in the UK with highly encouraging results. Interferon-beta was found to be safe and well tolerated in ARDS patients and the optimal tolerated dose was established. The selected pharmacodynamic marker for interferon-beta bioactivity showed clear dose response and the treatment target molecule (CD73) levels were induced during the dosing period. Most importantly, interferon-beta treatment significantly reduced the all-cause mortality at day 28, the primary end point of the study, compared to the control cohort (Bellingan et al. 2014, Lancet Respiratory Medicine). Traumakine was associated with an 81% reduction in odds of 28-day mortality. Based on these highly encouraging results, a much larger clinical trial has been designed. Ongoing Phase III INTEREST study This second, presently ongoing, clinical trial is a Phase III double-blind, randomised, parallel-group comparison of efficacy and safety of interferon-beta and placebo in the treatment of patients with moderate to severe ARDS. The study named INTEREST is to be conducted in 55 hospitals in Belgium, Finland, France, Germany, Italy, Spain and UK and 300 ARDS patients in total will be recruited. INTEREST has received funding from the European Union Seventh Framework Programme (FP7). Watch the Traumakine® video PIPELINE › PROGRAMMES › TRAUMAKINE CLINICAL PROGRAMME › THERAPEUTIC AREAS › PARTNERS PRINT SHARE FOLLOW US ON LINKED IN Faron Pharmaceuticals Joukahaisenkatu 6, Intelligate FIN-20520 TURKU Finland Phone: +358 2 469 5151 Fax: +358 2 469 5152 Email: info@faronpharmaceuticals.com Subscribe now Keep updated with Company news and events. YOUR EMAIL ADDRESS