Faron's Traumakine approved as investigational new drug

Clinical-stage biopharmaceutical company Faron Pharmaceuticals announced on Wednesday that the US Food and Drug Administration (FDA) has approved the investigational new drug (IND) application for ‘Traumakine’ - its wholly-owned product for the treatment of acute respiratory distress syndrome (ARDS), which is part of the regulatory process towards Biologics License Application (BLA) submission.

The AIM-traded firm said the FDA had already proposed that Faron could proceed directly to BLA, pending positive results from the two ongoing Phase III trials - INTEREST in Europe and MR11A8-2 in Japan - with the IND forming part of the process towards BLA submission.

Faron said it was also continuing to consider providing access to Traumakine in the US to ARDS patients under an expanded access program, which requires an IND.

Top-line data from the INTEREST study was due in the first half of 2018.

Faron said it was also planning to conduct a small open-label study in the US for pharmacological purposes, with the IND allowing opening of clinical activities in the country.

It explained that the first US study would target Traumakine in moderate and severe ARDS patients, especially with end organ - kidney and liver - failures.

“We are very pleased to receive this IND approval from the FDA which will allow us to further advance our Traumakine plans in the US,” said Faron CEO Dr Markku Jalkanen.

“It also allows rolling dossier build up for FDA, which can speed up the final BLA acceptance.

“With data expected in H1 2018 and, following previous guidance from the FDA, we remain hopeful that we can expedite Traumakine's route to market addressing this significant unmet medical need in terms of reducing mortality and providing savings for healthcare systems.”