Faron Pharmaceuticals said Friday that Independent Data Monitoring Committee (the IDMC) has recommended that the Interest trial for Traumakine should continue as planned with no changes, consistent with the previous four IDMC recommendations. Faron said it expects to recruit 300 patients during the fourth quarter of 2017.
INTEREST Phase III study is treating patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS) with its lead product Traumakine.
As the INTEREST Phase III study nears completion, Faron plans to initiate an expanded access program for Traumakine to start once the trial is closed to new patients.
ARDS is an 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.
Dr Markku Jalkanen, Chief Executive Officer of Faron Pharmaceuticals, said: “The trial is now moving into its final stages and we look forward to closing recruitment during the fourth quarter of 2017. Given this imminent completion, and based on the potential benefits that Traumakine could offer, further supported by another successful safety review, we plan to set up a compassionate use program for named patients with this severe disease following closure of the trial. The aim of this program is to provide continued access to Traumakine once the INTEREST trial sites close, until conclusion of the regulatory approval process.”