Faron Pharmaceuticals Oy (LON:FARN) has found more evidence to support its hypothesis on the mystifying outcome of a trial of its interferon-beta drug Traumakine.
As previously announced, a phase III clinical trial – dubbed “INTEREST” - on patients with a condition called acute respiratory distress syndrome didn’t yield the anticipated results, and the YODA study was instigated to find out why.
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 use of IFN (interferon) beta-1a and prednisolone at the same time during the part III trial reduced INF beta-1a action, compared to subjects who received IFN beta-1a alone, Faron asserted.
The reduced action was evident during the YODA trial through clinical signs of the subjects and also the reduction of cluster of differentiation 73 (CD73) activity responses measured from blood samples of these subjects; CD73 is a protocol used for the identification and investigation of cell surface molecules.
For the final statistical analysis, 10 subjects were included in the Traumakine group (two of the original 12 dropped out due to strong "flu reaction") and 12 subjects were in the group receiving Traumakine in combination with prednisolone. The statistical area under curve difference in CD73 activity between the two groups (10 versus 12 subjects) was p = 0.087.
Faron said 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 condition, acute respiratory distress syndrome. Traumakine is designed to prevent this leakage by increasing the response to the CD73 stimulus.
“These YODA results once again are consistent with the INTEREST data, supporting the conclusion that co-administration of steroids with Traumakine in patients inhibited interferon beta action,” declared Dr Markku Jalkanen, the chief executive officer of Faron.
“These findings are significant in explaining the lack of clinical response to Traumakine in the INTEREST trial. The YODA report will become an essential part of our communication dossier with the FDA [US Food and Drug Administration] and EMA [European Medicines Agency] when we justify our clinical double-dummy design for the concomitant use of steroids for the next Traumakine studies," he added.