Faron Pharmaceuticals has reported that its Japanese licensing partner Maruishi Pharmaceutical has recruited the first patient in the Phase III pivotal clinical trial for the treatment of acute respiratory distress syndrome (ARDS) with FP-1201-lyo (also known as Traumakine) within the country.
Faron recently secured the second IDMC (Independent Data Monitoring Committee) recommendation to continue the INTEREST pan-European Phase III trial with Traumakine without any modifications.
ARDS is a severe orphan disease with a mortality rate of approximately 30% to 45%. There is currently no approved pharmacological treatment available.
It is characterised by widespread capillary leakage and inflammation in the lungs, most often as a result of pneumonia, sepsis, or significant trauma.
A previous Phase I/II trial conducted in the UK indicated a decline in the odds of all-cause mortality on day 28 of 81%.
A Phase II trial in Japan was completed with comparable mortality results and no observed severe adverse events were announced in January.
The Japanese Phase III clinical trial (JapicCTI-163320) is a double-blinded, randomised, parallel-group comparison of efficacy and safety of FP-1201-lyo against placebo in the treatment of 120 patients with moderate-to-severe ARDS.
The commencement of the Japanese study means that the Pan-European and Japanese Phase III trials combined aim to treat maximum 420 moderate-to-severe ARDS patients with results expected to become available in 2017-2018.
Faron CEO Dr Markku Jalkanen said: “We are delighted that patient recruitment for the Japanese Phase III trial has commenced, as this trial will significantly increase the total number of patients in Traumakine pivotal studies.
"It was also encouraging to receive the second IDMC recommendation for the INTEREST pan-European Phase III trial continuation demonstrating the studies are progressing in line with protocol expectations and design.”
