Faron Pharmaceuticals (AIM:FARN, OTC:FPHAF) Oy (First North:FARON) said researchers had begun dosing its first patient as part of a phase II/III trial of its lead asset in people fighting the effects of Covid.
Traumakine is an intravenous Interferon beta-1a that is also being developed for acute respiratory distress syndrome, severe kidney injury, cardiac protection and the prevention of solid organ transplant failure.
The HIBISCUS study will be conducted across 10-15 sites in the US and will enrol 140 patients who require low flow oxygen support, but not mechanical ventilation.
Patients will be split into two groups in the randomised assessment – one receiving the Faron drug, the other a corticosteroid treatment with dexamethasone.
The team will assess the drug’s efficacy at the 14-day stage – this is called the primary endpoint of the evaluation. However, there will be two critical secondary follow-ups 28 and 90 days.
"There are currently limited treatment options for hospitalized COVID-19 patients, many of whom spend months in the hospital and face the potential of lifelong complications associated with their disease," said Daniel Talmor, the study’s principal investigator.
"We are pleased to commence this pivotal phase II/III trial as we believe intravenous IFN beta-1a has the potential to become a powerful treatment option for patients who are at risk of developing acute respiratory distress syndrome as a consequence of a viral infection, such as COVID-19."