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Final results from YODA study
Final results from YODA study.
About this update from Faron Pharmaceuticals Oy
[{"type":"text","content":"\n \nRNS Number : 1801C Faron Pharmaceuticals Oy 14 June 2019 \n\nFaron Pharmaceuticals Oy\n(\"Faron\" or the \"Company\")\n \nFinal results from YODA study confirm previously reported findings\n \nTURKU - FINLAND, 14 June 2019 - Faron Pharmaceuticals Oy (AIM: FARN), the clinical stage biopharmaceutical company, today announces results from its pharmacokinetic/dynamic YODA study examining the administration of concomitant steroids and Traumakine in healthy volunteers.\n \nAs previously reported, the post-hoc analysis of the phase III INTEREST study had indicated significant reduction of interferon-beta (\"IFN-beta\") action by steroids and this finding was also observed in the Japanese phase III study. Steroid interference with IFN-beta was also reported in ex vivo human lung tissues and human primary lung endothelial cells. The YODA study was set out to further investigate this observed finding in a prospective study setting in human healthy volunteers by administrating Traumakine alone or Traumakine in combination with prednisolone (a corticosteroid).\n \nAs previously announced, parts I and II of the YODA study confirmed that the INTEREST study drug produced the expected levels of bioactivity, suggesting that drug formulation was not a factor in the outcome of the INTEREST trial and this observation was confirmed during part III of the YODA trial. The concomitant use of IFN beta-1a and prednisolone during part III reduced IFN beta-1a action, compared to subjects who received IFN beta-1a alone. This was evident during the YODA trial through both clinical signs of the subjects (fever, which is a typical pharmacodynamic effect of interferon beta-1a) and reduction of cluster of differentiation 73 (CD73) activity responses measured from blood samples of these subjects. For the final statistical analysis, 10 subjects were included in the Traumakine group (two drop outs due to strong \"flu reaction\") and 12 subjects in the group receiving Traumakine in combination with prednisolone. The statistical AUC (area under curve) difference in CD73 activity between the two groups (10 versus 12 subjects) was p = 0.087. CD73 is regarded as the key molecule to maintain the endothelial barrier, which if it leaks, can cause impaired lung function and result in the life-threatening syndrome, ARDS. Traumakine is designed ...