Maruishi recruits first Traumakine Phase III patient in Japan for treatment of acute respiratory distress syndrome

Faron has also recently received 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 reported mortality rate of approximately 30–45%, 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. An earlier Phase I/II trial conducted in the UK and published in The Lancet Respiratory Medicine, (Bellingan et al. 2014: 2: 98-107), showed a decline in the odds of all-cause mortality at day 28 of 81%. A Japanese Phase II trial was completed with comparable mortality results and no observed severe adverse events as announced in January 2016.

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 maximum 120 patients with moderate to severe ARDS. The initiation 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.

Dr Markku Jalkanen, CEO of Faron 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.”