Faron Pharmaceuticals Oy (LON:FARN) (FIRSTNORTH:FARON) said it has amended the protocol for a second phase III study of its drug for acute respiratory distress syndrome (ARDS) to reflect input from the US regulator.
Following a meeting with the Food & Drug Administration, the company’s treatment of patients with its interferon-beta (IFN-beta) medication Traumakine will exclude the overlapping use of steroids.
It is suspected steroids have a blocking - or as Faron called it, “a potentially deleterious impact” - on patient outcomes.
This chimes with a World Health Organisation (WHO) recommendation on the use of steroids in people with coronavirus, who in severe cases, are susceptible to ARDS.
WHO reckons steroids block the internal, bodily (endogenous) production of IFN-beta. Faron believes drugs such as Traumakine could be used to aid the internal production of interferon.
In a statement, Faron's chief executive, Dr Markku Jalkanen said: "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."
He added: "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.”
Shares nudge higher
The Faron share price ticked 1.8% higher late morning to 230p, valuing the business at just shy of £100mln.
Analysts at Panmure Gordon said the recent outbreak of coronavirus is likely to increase interest in Traumakine.
However, the immediate challenge for Faron is finding a funding partner for the phase III trial, the City broker said. This, in turn, will require regulatory sign-off for the study, it added.
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