Faron Pharmaceuticals Ltd’s (LON:FARN) said patient recruitment has started for a pivotal Japanese clinical trial for its treatment for acute respiratory distress syndrome (ARDS).
Faron’s Japanese licensing partner, Maruishi Pharmaceutical, has recruited the first patient in the Japanese Phase III pivotal clinical trial for the treatment of ARDS with FP-1201-lyo (also known as Traumakine).
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ARDS is a disease with a reported mortality rate of around 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 (organ failure), or significant trauma.
It is an orphan disease, which means that any treatments designed to treat it generally get fast-tracked by the regulatory authorities as an inducement to target a disease that otherwise would not be cost effective for the drugs companies to address.
Traumakine is Faron’s flagship drug candidate and it is attracting a lot of interest. The treatment is already in phase III trials in Europe and licences have been picked up by three companies in Asia, including a deal with Korean firm Pharmbio.
An earlier Phase I/II trial conducted in the UK and published in The Lancet Respiratory Medicine journal 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 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.
“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,” said Dr Markku Jalkanen, chief executive officer of Faron.
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.
“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," Jalkanen added.