Faron Pharmaceuticals Oy (AIM:FARN, OTC:FPHAF) has halted a trial of a COVID-19 treatment due to low hospitalisation rates and a shortage of patients that have not already received steroids as part of their remedy.
The Phase II/III HIBISCUS trial was assessing Traumakine (intravenous interferon beta-1a; IFN beta-1a) as a first-line treatment for hospitalised COVID-19 patients who required low flow oxygen support.
Faron said the decision was based on a recommendation from the trial’s Independent Data Monitoring Committee (IDMC).
"When the HIBISCUS trial was designed and initiated, infection and hospitalisation rates were high across the US," said Markku Jalkanen, Faron’s chief executive.
"The emergence of the less severe omicron variant and widespread vaccinations led to a significant decrease in the number of hospitalised patients requiring low flow oxygen support.
“While this was good news from a pandemic perspective, it, along with the widespread early use of steroids, severely limited our potential patient pool. “
Jalkanen said Faron will now focus on the development of its cancer treatment bexmarilimab, with data from the HIBISCUS study used to explore Traumakine’s potential as a treatment for multiple acute settings of ischemia and systemic inflammation.
"We know that intravenous interferon beta-1a can up-regulate CD73, which reduces inflammation and prevents vascular leakage," said Daniel S. Talmor, chief of anesthesia at Beth Israel Deaconess Medical Center and principal investigator of the HIBISCUS trial.
“While the timing and scope of the HIBISCUS trial did not allow us to efficiently enrol patients, I believe strongly that Traumakine has the potential to become a powerful treatment option for patients who are at risk of developing major inflammation.”