Faron Pharmaceuticals reports 'significant' findings from YODA study
By Josh White
Date: Friday 14 Jun 2019
(Sharecast News) - Clinical stage biopharmaceutical company Faron Pharmaceuticals announced results from its pharmacokinetic/dynamic 'YODA' study examining the administration of concomitant steroids and Traumakine in healthy volunteers on Friday.
The AIM-traded firm had previously reported that the post-hoc analysis of the phase III 'INTEREST' study had indicated significant reduction of interferon-beta (IFN-beta) action by steroids, with that finding 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 that observed finding in a prospective study setting in human healthy volunteers, by administering Traumakine alone or Traumakine in combination with prednisolone - a corticosteroid.
As it had also 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 that 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.
That was said to be 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 those subjects.
For the final statistical analysis, 10 subjects were included in the Traumakine group - two drop outs occurred due to strong 'flu reaction' - and 12 subjects in the group receiving Traumakine in combination with prednisolone.
The statistical area under curve (AUC) difference in CD73 activity between the two groups was p = 0.087.
CD73 was regarded as the key molecule to maintain the endothelial barrier, which if it leaked, can cause impaired lung function and result in the life-threatening syndrome ARDS.
Traumakine was designed to prevent that leakage by upregulating CD73 expression.
"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," said Faron chief executive officer Dr Markku Jalkanen.
"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 and EMA when we justify our clinical double dummy design for the concomitant use of steroids for the next Traumakine studies."
The company said it currently expected to receive the 'INFORAAA' interim results in the near future, allowing full review of all the Traumakine data with key opinion leaders and to make final decisions on Traumakine's development.
It said it currently envisaged that a further Traumakine trial was likely to be funded through third party funding.
Low concomitant corticosteroid use was expected during the INFORAAA trial.
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