Traumakine® Clinical Programme
The first indication that Traumakine®'s clinical programme addresses is the treatment of Acute Respiratory Distress Syndrome (ARDS), which is a life threatening condition. ARDS is an orphan lung disease with currently no approved pharmaceutical treatment.
Traumakine® is also being investigated in a second indication for the prevention multi-organ failure and mortality among operated RAAA (Ruptured Abdominal Aortic Aneurysm) patients.
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 approximately 60 hospitals across 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).
In addition to the pan-European Phase III (INTEREST) study, Faron´s Japanese licensing partner Maruishi Pharmaceutical Co., Ltd. is conducting a Phase III Traumakine study in Japan. The two Phase III trials combined aim to treat all 420 moderate to severe ARDS patients in total.
A European Phase II trial with Traumakine (the INFORAAA trial) is underway for the Rupture of Abdominal Aorta Aneurysm (“RAAA”).