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LONDON (Alliance News) - Faron Pharmaceuticals Ltd said Monday that it has found evidence suggesting that corticosteroids used in parallel to its Traumakine treatment had a significant effect on mortality in the trial.
Faron shares were trading down 18% at 95.35 pence each.
Earlier this year, Faron had reported unsuccessful results from the testing of Traumakine in a phase III INTEREST trial for the treatment of acute respiratory distress syndrome.
In early May, Faron had reported "extremely disappointing" phase III results for Traumakine compared to a placebo.
The company decided to carry out further "post-hoc data analysis", which discovered that concomitant use of corticosteroids and Traumakine appeared to affect both the mortality and biomarker appearance in the INTEREST study patients.
The new results showed that the rate of mortality was 11% for the patients receiving Traumakine and not on corticosteroids, versus 40% for those receiving Traumakine and on corticosteroids.
Faron Chief Medical Officer Matti Karvonen said: "At this stage it appears possible that unexpectedly high corticosteroid use in the INTEREST trial may have masked the treatment benefit of Traumakine in acute respiratory distress syndrome patients."
The company is awaiting results from two further studies to decide the next steps for Traumakine's development.
