Faron doses first patient in Covid-19 treatment trial

Clinical-stage biopharmaceuticals company Faron Pharmaceuticals announced on Wednesday that the first patient has been dosed in the phase 2 and 3 ‘HIBISCUS’ trial, assessing ‘Traumakine’, or intravenous interferon beta-1a, as a first-line treatment for hospitalised Covid-19 patients.

The AIM-traded firm said Traumakine is an investigational therapy it developed for the potential treatment of acute respiratory distress syndrome (ARDS), acute kidney injury, cardiac protection, prevention of solid organ transplant failure and ischemia reperfusion injury.

It said the HIBISCUS study was being conducted in 10 to 15 study sites across the United States, and would enroll 140 patients who required low flow oxygen support, but not mechanical ventilation.

Patients would be randomised one-to-one across two study arms, to assess the safety and efficacy of Traumakine compared to corticosteroid treatment with dexamethasone.

As part of the trial protocol, corticosteroid treatment concomitantly with Traumakine was not possible in the study setting, but would be enabled in a sequenced manner following treatment with Traumakine.

The primary efficacy endpoint was clinical status at day 14, with key secondary endpoints including clinical status at day 28 and in-hospital mortality at days 28 and 90.

“Despite the progress that has been made with vaccinations, there remains a critical need to identify effective treatment options for hospitalized Covid-19 patients,” said chief executive officer Dr Markku Jalkanen.

“As we continue to gain insight into the potential benefit of IFN beta-1a as the body's first line of defense against viral infection, we believe Traumakine will be advantageous over current standard of care to protect lung function post Covid-19 infection.

“We are proud to be engaged in research to support the ongoing global response to Covid-19 and are pleased to be working with the US Department of Defense and the team at Harvard University's Beth Israel Deaconess Medical Center on this study.”

In January, Faron announced that the US Department of Defense (DoD) had selected the HIBISCUS trial to receive $6.1m of funding under the Coronavirus Aid, Relief, and Economic Security (CARES) Act.

Additionally, as part of an ongoing working relationship established with Faron, the 59th Medical Wing of the US Air Force and the DoD were continuing preclinical studies to evaluate Traumakine's role in preventing multiple organ dysfunction syndrome after ischemia-reperfusion injury caused by a major trauma.

At 1121 BST, shares in Faron Pharmaceuticals were up 3.53% at 471.05p.