Top-line trial data were previously reported on 8 May 2018 and an update was provided on 11 May 2018.
The biomarker data confirms that Traumakine treatment did not produce consistent interferon-beta bioactivity across the treatment group. A retrospective stratification of Traumakine treated patients has been conducted, based on subjects in the INTEREST trial that demonstrated a defined biomarker response.
These were defined as patients with a 2-fold increase in CD73 serum levels during the first seven days of treatment and 3-fold MxA activation (during the first four days of treatment) in peripheral blood cells.
This sub-group of patients (n=48) demonstrated a reduced D28 all-cause mortality, with a mortality rate of 14.6% compared to 32.3% in the remaining patients (n=96) in the Traumakine treatment arm (p=0.02). In addition, this sub-group of patients demonstrated a trend toward an increase in ventilator free days at D28, with 16 ventilator free days (VFDs) compared to 6.5 days (p=0.06).
While these remain initial findings, this data suggests a correspondence to previous results observed in the Phase II study. In the Phase II trial patients with an elevated MxA and CD73 biomarker response also demonstrated an improved D28 mortality and reduced need for ventilation compared to patients with low or no increase in biomarkers.
Faron CEO Dr Markku Jalkanen said: "We have observed that a sub-group of patients with higher levels of biomarkers in the INTEREST trial did demonstrate reduced mortality and increased ventilator free days, as expected based on the positive Phase II study.
“While this is encouraging this still does not explain many of the other results observed from the trial including why Traumakine activity was variable in the INTEREST trial compared to previous studies nor the low mortality of the placebo group. This analysis will continue and we will keep our shareholders and the market informed with progress in due course."
The INTEREST trial was a Phase III double-blind, randomised, parallel-group comparison to assess the efficacy and safety of Traumakine® (FP-1201-lyo) versus placebo in the treatment of patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS). The study, which recruited 300 patients, was conducted in 64 hospital intensive care units (ICU) in Belgium, the Czech Republic, Finland, France, Germany, Italy, Spain and the UK.
ARDS is a severe orphan disease with a reported mortality rate of approximately 30-45%1,2,3 for which there is currently no approved pharmacological treatment. It is characterised by widespread capillary leakage and inflammation in the lungs, most often as a result of pneumonia (e.g. following a pandemic influenza), sepsis, or significant trauma. Faron estimates there are around 300,000 plus annual cases in Europe and US alone.
Source: Company Press Release