First patient recruited for Phase III Japanese acute respiratory distress syndrome trial
Posted: 27 October 2016 | | No comments yet
The Japanese Phase III clinical trial is a double-blinded, randomised, parallel-group comparison of efficacy and safety of FP-1201-lyo against placebo…
Faron Pharmaceuticals’ Japanese licensing partner Maruishi has recruited the first patient in the Japanese Phase III clinical trial for the treatment of acute respiratory distress syndrome (ARDS), with FP-1201-lyo (Traumakine).
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.
About the Phase III trial
The Japanese Phase III clinical trial 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.
Watch to find out the Traumakine mechanism of action, presented by Professor Geoff Bellingan, medical director at University College London Hospitals (UCLH), who led the Phase II trial.
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, demonstrating the studies are progressing in line with protocol expectations and design.”
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, 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.
