Faron Pharmaceuticals pins some hope to YODA trial

Clinical stage biopharmaceutical company Faron Pharmaceuticals issued interim results from its pharmacokinetic/dynamic ‘YODA’ study on Wednesday, examining various formulations of recombinant human interferon-beta (IFN-beta).

The AIM-traded firm said that, further to its announcement on 22 October, the YODA study in around 50 healthy volunteers was being undertaken to understand the reduced biomarker response to Traumakine during the phase III INTEREST trial.

It said YODA trial results from the first 30 subjects indicated that IFN-beta, regardless of the method of solubilisation, produced the expected level of bioactivity, suggesting that drug formulation was not a factor in the outcome of the INTEREST trial.

Faron’s share price crashed in May after the INTEREST trial of Traumakine failed to meet its primary endpoints, and has languished near all-time lows since.

It said the YODA study would now examine concomitant administration of prednisolone and Traumakine in order to confirm, in vivo, the observed interference of corticosteroids on IFN-beta bioactivity in the INTEREST study and ex vivo lung samples.

Those YODA results were expected during the first quarter of 2019.

“We believe these results confirm that the drug product used in the INTEREST study was robust and effective,” said chief executive officer Dr Markku Jalkanen.

“While analysis continues, we believe the mixed results seen were due to a higher than anticipated placebo response due to high pneumonia portion, interference of corticosteroids on IFN-beta bioactivity and, as recently announced, the impact of a subgroup of patients' single nucleotide polymorphism C/T mutation in their interferon alpha and beta receptor gene.”

Faron said it was still awaiting top-line data from the Phase III ARDS trial with Japanese partner Maruishi, to help determine next steps for Traumakine's development.

It said that data, originally expected before the end of year, was now anticipated in early 2019.