Faron Pharmaceuticals (Faron), the Finnish clinical stage biopharmaceutical company, has recruited the first patient in the Japanese Phase III pivotal clinical trial for the treatment of acute respiratory distress syndrome (ARDS) with Traumakine, through its Japanese licensing partner Maruishi Pharmaceutical (Maruishi)
Faron has also recently received the second IDMC (Independent Data Monitoring Committee) recommendation to continue the Iinterest pan-European Phase III trial with Traumakine ( FP-1201-lyo)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, Faron has explained.
An earlier Phase I/II trial conducted in the UK and published in The Lancet Respiratory Medicine, 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, it has been said in Faron’s Monday press release.
Furthermore, 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.”