(Alliance News) - Faron Pharmaceuticals Oy on Friday said analysis of a more recent trial of Traumakine has explained why the drug did not perform as expected in a previous trial.
Shares in the clinical stage drug developer were up 15% at 145.02 pence in late morning trade.
This analysis is based on Faron Pharma's more recent Yoda study, which involved healthy volunteers who were either given Traumakine by itself or in combination with the steroid prednisolone.
The goal of the Yoda study was to find out why there had been a reduced biomarker response to Traumakine, which is intended to treat acute respiratory distress syndrome, in the phase 3 Interest study. When announcing the Interest result in May, Faron Pharma described it as "extremely disappointing".
Analysis of Yoda confirmed that taking the steroid reduced the action of Traumakine's active ingredient, interferon-beta-1a, compared to patients taking the drug without a steroid. As patients in the Interest study had been taking a steroid, this explained much of the reduced response.
Faron Pharma Chief Executive Markku Jalkanen said: "These Yoda results once again are consistent with the Interest data, supporting the conclusion that co-administration of steroids with Traumakine in patients inhibited interferon beta action. These findings are significant in explaining the lack of clinical response to Traumakine in the Interest trial. The Yoda report will become an essential part of our communication dossier with the [US Food & Drug Administration] and [European Medicines Agency] when we justify our clinical double dummy design for the concomitant use of steroids for the next Traumakine studies."
Faron Pharma (FARN)