Faron Pharmaceuticals Ltd, the clinical stage biopharmaceutical company, is pleased to announce the enrolment of the first patient in the Phase III INTEREST clinical programme for Traumakine for the treatment of acute respiratory distress syndrome (ARDS).
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 characterized by widespread capillary leakage and inflammation in the lungs, most often as a result of sepsis, pneumonia or significant trauma. In the earlier completed Phase I/II trial in respect of Traumakine the drug candidate was associated with an 81% reduction in the odds of 28-day mortality. Traumakine has been granted Orphan Drug Designation in Europe, which allows a period of 10 years of market exclusivity following marketing approval by the EMA.
The recruitment of the first patient, so soon after the company’s recent IPO, is consistent with the anticipated timeline of 12–18 months required to complete recruitment for the pivotal Phase III trial for Traumakine. The Phase III trial is being led by Professor Geoff Bellingan from University College London Hospital and Professor Marco Ranieri from the University of Rome.
Dr Markku Jalkanen, CEO of Faron said: “Following our successful IPO, we very much welcome the commencement of patient recruitment for the pivotal Phase III trial for this awful condition, which has significant unmet medical needs. Our previous exceptional results with an 81% reduction in odds of 28-day mortality of ARDS patients have excited our clinical network, which we expect will facilitate completion of patient recruitment within the anticipated time frame of 12-18 months. We believe that Traumakine presents a significant opportunity for those suffering from ARDS, the hospitals which treat them and the societies covering the recovery of ARDS patients.”
The Phase III clinical trial INTEREST is a double-blinded, randomized, parallel-group comparison of efficacy and safety of FP-1201-lyo (the lyophilized form of Traumakine) and placebo in the treatment of patients with moderate to severe ARDS. The INTEREST trial will be conducted through 55 hospitals in Belgium, Finland, France, Germany, Italy, Spain and UK with the target of recruiting 300 ARDS patients in total.
In addition to the orphan drug designation of Traumakine in Europe, the company has applied for the same orphan status in the US and will update shareholders in due course when the outcome of the company’s application is known.