Faron Pharmaceuticals Oy (LON:FARN, First North:FARON) said the US Food & Durg Administration (FDA) has approved the phase II/III trial of a drug being deployed to combat the acute symptoms of coronavirus (COVID-19).
Traumakine, an intravenous interferon beta-1a drug, will be given to people who have been hospitalised but who do not yet need ventilation. It will be administered before corticosteroids are given.
The aim is to prevent systemic inflammatory response syndrome (SIRS) and acute respiratory distress syndrome (ARDS) – and by extension improve sufferers’ condition and reduce the death rate among patients.
“IFN beta-1a has previously demonstrated a compelling scientific rationale as the body's first line of defence against viral infections and might be advantageous over current standard of care when given intravenously to patients suffering from COVID-19 induced ARDS,” said Faron chief executive Dr Markku Jalkanen in a statement.
“This trial will allow us to gain important insights into Traumakine's potential in this particular setting and we believe that this sequential administration of intravenous interferon beta, before corticosteroids, could become a standard of care in the future and as such have filed a patent application to protect the commercial opportunity.”
In all, around 140 coronavirus suffers will take part in Faron’s HIBISCUS study at five to 10 sites in the United States.
Traumakine will be measured against a placebo, which has no medical impact on the patient.
Faron’s research team, led by principal investigator Professor Daniel Talmor from Harvard University's Beth Israel Deaconess Medical Center, will assess patient status after two weeks.
This is what the company calls the ‘primary endpoint’ of the trial. Secondary endpoints include clinical status at day 28 and in-hospital mortality at day 28 and day 90.
An interim analysis of the study will take place once 70 people have been assessed for primary efficacy.
"There have been no innovative new drugs in the field of emergency care for decades and it remains a highly underserved area of medicine in respect to therapeutics,” said CEO Jalkanen.
“We strongly believe that vital organs can be better protected by the induction of CD73 and so we are pleased to be continuing the development of Traumakine through a number of important trials and collaborations.”
Faron said last week the Department of Defense had selected the phase II/III HIBISCUS study to receive US$6.1mln under the Coronavirus Aid, Relief, and Economic Security, or CARES Act.