Traumakine treatment optimal for particular subgroup, Faron finds

Clinical stage biopharmaceutical company Faron Pharmaceuticals has identified, by genetic testing, an “optimal subgroup” of acute respiratory distress syndrome (ARDS) patients for Traumakine treatment who showed a substantial reduction in mortality during the INTEREST trial, it announced on Wednesday.

The AIM-traded firm said multivariate regression analyses that adjusted for disease severity indicated that patients receiving interferon beta-1a treatment (Traumakine) and carrying the single nucleotide polymorphism rs9984273 in subunit two of the interferon alpha and beta receptor had 5.7 times greater likelihood of survival at day 28 than patients without that mutation.

It claimed that no similar survival effect was seen for the C/T polymorphism in the placebo group.

Faron said that suggested that together, the C/T mutation and Traumakine treatment was the most favorable combination for patient outcome and interferon treatment efficacy.

The D28 overall mortality of the group was 11.1% despite receiving, or not receiving, concurrent steroids.

In patients with the C/T polymorphism who received Traumakine but not concurrent steroid treatment, mortality was 4.2%.

Faron said it intended to file the data with regulatory authorities in the first quarter of 2019, and to seek advice on the future clinical development of Traumakine in the EU and the US for the “precision” treatment.

The prevalence of the unique polymorphism was around 30-35% among Caucasians, 40-45% among patients of African origin, and 10% in Asian populations, indicating a target population of around one third of ARDS patients in Europe and North America for whom Traumakine treatment could potentially be most effective and life saving.

“We have, and are continuing to build, a solid body of evidence which indicates that there is clearly a subgroup of patients for whom Traumakine treatment could potentially be very effective,” said Faron chief executive officer Dr Markku Jalkanen.

“The identification of these C/T patients is very easy with PCR-based analysis of a patient's DNA sample and provides a way to target this precise group of ARDS patients, representing around one third of all ARDS patients.”

Dr Jalkanen said the finding had also allowed the company to build further intellectual property for Traumakine, as the association had not been previously reported.

“This protection has been filed and, if approved, could extend beyond 2040.”