Updated on 8 January 2016
Finland-based clinical stage biopharmaceutical company Faron Pharmaceuticals Ltd has announced that its Japanese licensing partner Maruishi Pharmaceutical Co Ltd has obtained positive results from the phase II Japanese study for Traumakine conducted by Maruishi in Japan.
Traumakine is in development for the treatment of acute respiratory distress syndrome (ARDS). Based on these results Maruishi is now planning the next pivotal clinical trial to be conducted in Japan.
Commenting on the approval, Dr Markku Jalkanen, CEO of Faron, said, "Following the announcement of the first patient recruitment for our pivotal phase III Pan-European INTEREST trial, we very much welcome the positive news of the Japanese phase II study. The trial results reported by Maruishi are extremely encouraging, particularly as the trial included very sick ARDS patients, yet still resulted in relatively low mortality rates. We are happy to learn that Maruishi is now planning the next pivotal clinical trial which will enable them to move towards filing of Traumakine's marketing approval in Japan."
The phase II study (JapicCTI-142716) was conducted at 15 intensive care unit facilities in Japan, from February to December 2015. A total of 18 ARDS patients were recruited, 12 of whom had moderate ARDS and six with severe ARDS.
ARDS is a severe, life-threatening medical condition characterized by widespread inflammation in the lungs and sudden failure of the respiratory system. ARDS causes inflammation of the alveoli in the lungs, which are unable to perform the normal oxygenation of blood. It is characterized by rapid breathing, difficulty getting enough air into the lungs and low blood oxygen levels.