Faron Pharmaceuticals Oy (FARN) revealed on Thursday it has updated its proposed study design and has submitted the amended trial protocol to the FDA.
The clinical stage biopharmaceutical firm provided an update on Traumakine's clinical continuation following a meeting with the U.S. Food and Drug Administration (FDA) in December 2019.
The Traumakine study design was submitted after feedback from the FDA regarding the design of the next study and receiving the agreed meeting minutes.
Specifically, Faron said the trial protocol has been amended to reflect the FDA's feedback that further studies with interferon-beta (IFN-beta) should exclude the use of overlapping steroids.
This is due to the fact that they are likely to block the desired therapeutic effect of Traumakine and may have a ‘potentially deleterious’ impact on patient outcomes, Faron said in a statement on Thursday.
Faron said it will continue to work with the FDA to achieve final approval for the next study.
Shares in Faron were trading 2.88% higher on Thursday
The company also highlighted a recent recommendation by the World Health Organization (WHO) that steroids should not be used on coronavirus infected patients.
The company said exogenous IFN-beta (like Traumakine) can strengthen further endogenous IFN-beta action and provide maximal protection against viral infections, without concomitant corticosteroids which have the capacity to disturb or block IFN-beta action.
Dr. Markku Jalkanen, Faron's CEO, commented: "With no currently approved pharmacological treatments available, ARDS remains a significant problem for patients and healthcare systems. We are pleased to note that the WHO has recognised the risk of using corticosteroids on patients with coronavirus, which aligns with our findings from post-hoc analysis of the INTEREST study.”
"One of the main first lines of defence against viral infection is endogenous interferon-beta production.”
“Faron believes Traumakine treatment, in the absence of concomitant corticosteroid use, can further strengthen this endogenous IFN-beta action and provide increased protection against serious lung complications arising from viral infections. Faron remains committed to developing Traumakine for the potentially fatal condition ARDS."
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