Faron sees some encouraging data in ongoing INTEREST analysis

Clinical stage biopharmaceutical company Faron Pharmaceuticals announced preliminary biomarker data from its Phase III INTEREST trial of ‘Traumakine’ for the treatment of acute respiratory distress syndrome (ARDS) on Thursday, reporting that the data confirmed that Traumakine treatment did not produce consistent interferon-beta bioactivity across the treatment group.

The AIM-traded firm said a retrospective stratification of Traumakine-treated patients had been conducted, based on subjects in the INTEREST trial that demonstrated a defined biomarker response.

They were defined as patients with a twofold increase in CD73 serum levels during the first seven days of treatment, and threefold MxA activation during the first four days of treatment in peripheral blood cells.

That sub-group of 48 patients demonstrated a reduced D28 all-cause mortality, with a mortality rate of 14.6% compared to 32.3% in the remaining 96 patients in the Traumakine treatment arm, Faron reported.

In addition, it said the sub-group of patients demonstrated a trend toward an increase in ventilator-free days at D28, with 16 ventilator free days, compared to 6.5 days.

While they remain initial findings, the company said the data suggested a correspondence to previous results observed in the Phase II study.

In the Phase II trial, patients with an elevated MxA and CD73 biomarker response also demonstrated an improved D28 mortality and reduced need for ventilation compared to patients with low or no increase in biomarkers.

“We have observed that a subgroup of patients with higher levels of biomarkers in the INTEREST trial did demonstrate reduced mortality and increased ventilator free days, as expected based on the positive Phase II study,” said Faron chief executive officer Dr Markku Jalkanen.

“While this is encouraging this still does not explain many of the other results observed from the trial including why Traumakine activity was variable in the INTEREST trial compared to previous studies nor the low mortality of the placebo group.

“This analysis will continue and we will keep our shareholders and the market informed with progress in due course.”

The firm described the INTEREST trial as a Phase III double-blind, randomised, parallel-group comparison to assess the efficacy and safety of Traumakine (FP-1201-lyo) compared to placebo in the treatment of patients with moderate to severe ARDS.

It said the study, which recruited 300 patients, was conducted in 64 hospital intensive care units in Belgium, the Czech Republic, Finland, France, Germany, Italy, Spain and the UK.

The company added that it had initiated a cash preservation program by suspending the Traumakine commercialisation activities and regulatory filings, and minimising the cost burden on Traumakine manufacturing and general and administrative costs.

Its board said it was working to ensure that the company's cash position was preserved, and that value would be delivered to shareholders.

Faron had €18.7m of cash at the end of the first quarter.