Faron Pharmaceuticals has received the Independent Data Monitoring Committee’s (IDMC) recommendation to continue the INTEREST Phase III study for the treatment of patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS) with its lead product Traumakine.
Faron said that the IDMC will provide the next advanced recommendation after reviewing the data at 240 recruited patients which is expected to happen in the third quarter of 2017.
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 with around 300,000 annual cases in Europe and US, Faron said.
Dr Markku Jalkanen, Chief Executive Officer of Faron Pharmaceuticals, commented: “We were again very delighted to learn that the IDMC gave us another recommendation to continue the INTEREST study as planned. We are looking forward to their next recommendation in Q3 2017, which we hope to confirm our plans for the future of the product and for ARDS patients.”