Faron Pharmaceuticals confirms publication of 'crucial' study

(Sharecast News) - Clinical-stage biopharmaceutical company Faron Pharmaceuticals announced on Wednesday that the results of its detailed analyses into the effects of glucocorticoids on intravenous interferon beta-1a activity, which arose following the 'INTEREST' trial in 2018, had been published in critical care journal Intensive Care Medicine.
The AIM-traded firm said the results showed that the desired mechanism of action of intravenous interferon beta-1a in the lung vasculature - the upregulation of CD73 - was blocked by the administration of glucocorticoids.

In addition, the administration of glucocorticoids with intravenous interferon beta-1a increased mortality in patients with acute respiratory distress syndrome, compared to patients administered with intravenous interferon beta-1a alone.

As it had previously announced, Faron said analysis from the INTEREST trial showed day 28 mortality for patients receiving concomitant glucocorticoids with intravenous interferon beta-1a was 39.7%, compared to 10.6% for patients receiving intravenous interferon beta-1a alone.

"This is a crucial publication for the critical care community, detailing the important scientific detective work that has been undertaken since the unexpected readout from the INTEREST trial," said chief executive officer Dr Markku Jalkanen.

"It is especially important in these times when intensive care units are filled with Covid-19 patients, many of whom may be receiving treatment with glucocorticoids.

"Prior clinical data have shown that glucocorticoids are harmful in viral-induced ARDS and the World Health Organization has already recommended not to use glucocorticoids in severely ill Covid-19 patients."

Dr Jalkanen said the published and peer-reviewed data showed the mechanistic reason behind that, with the results described as being "without dispute".

"The potential lung protective effects of interferon beta through upregulation of CD73, should it be endogenous or exogenous, are lost with the administration of glucocorticoids."

In recent weeks, Faron had announced that its investigational intravenous interferon beta-1a, or 'Traumakine', was being trialled in two global studies investigating potential Covid-19 treatments.

Those are the World Health Organization's 'Solidarity' study, involving more than 90 countries, and the global REMAP-CAP trial underway across close to 200 sites in 14 countries.

The company said it was continuing to develop Traumakine as a treatment for ARDS patients.

As it announced in March, the US Food and Drug Administration (FDA) accepted Faron's proposed protocol design for the next Traumakine study, which would exclude the use of concomitant glucocorticoids.

At 1020 BST, shares in Faron Pharmaceuticals were up 1.52% at 368p.