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LONDON (Alliance News) - Biopharmaceutical firm Faron Pharmaceuticals Oy on Monday said recruitment for its Japanese Phase III clinical trial into its Traumakine product has commenced.
The trial will evaluate the efficacy and safety of Traumakine as a treatment for acute respiratory distress syndrome, a severe orphan disease with a reported mortality rate of around 30% to 45%.
Faron said the first patient for the Phase III trial was recruited by its Japanese licensing partner Maruishi Pharmaceutical Co Ltd. The Phase III trial will test the treatment against a placebo, with up to 120 patients to take part.
This follows the completion of a Phase I/II trial in the UK where the odds of an all-cause mortality at day 28 declined 81%. A Japanese Phase II trial was then completed, in which there were no severe adverse events and comparable mortality results.
Faron on Monday said it has also received the second independent data monitoring committee recommendation to continue the INTEREST pan-European Phase III trial with Traumakine without any modifications.
The initiation of the Japanese study means that the pan-European and Japanese Phase III trials combined aim to treat maximum 420 moderate to severe acute respiratory distress syndrome patients with results expected to become available in 2017-2018.
"We are delighted that patient recruitment for the Japanese Phase III trial has commenced as this trial will significantly increase the total number of patients in Traumakine pivotal studies," said Chief Executive Markku Jalkanen.
Shares in Faron were up 2.0% at 260.00 pence on Monday morning.
By Hannah Boland; hannahboland@alliancenews.com; @Hannaheboland
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