Biopharma Faron Pharmaceuticals Oy (LON:FARN) has made another “important step” with its acute respiratory distress syndrome drug, Traumakine.
The AIM-quoted company has now completed recruitment for the phase III INTEREST trial which is comparing the efficacy and safety of Traumakine and a placebo in patients with moderate to severe ARDS.
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A total of 300 patients will now take part in the trials which are being conducted in more than 60 intensive care units in Belgium, Finland, France, Germany, Italy, Spain, UK and Czech Republic.
What investigators will be looking for is the all-cause mortality rate at day 28, which Faron hopes will fall to 15% from around 30%.
On top of the 28-day mortality endpoint, Faron said on Monday it will also report patient data at 90 days.
Top-line data from the trial is due in the first half of next year, while data from Faron’s Japanese partner, Maruishi, is also expected in 2018.
"We are extremely pleased to have completed recruitment for the INTEREST study within our expected timelines and are grateful for all parties involved in reaching this milestone,” said chief executive Markku Jalkanen.
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“Closing the recruitment marks another important step for Traumakine and Faron. Our focus is now on closing the data basis for read-out purposes and bringing this product to the market as expeditiously as possible in order to provide patients with this life threatening condition a treatment option where currently there is none.”
ARDS is a severe lung disease which has a typical mortality rate of between 30-45%, for which there is no current pharmacological treatment.
It is characterised by widespread capillary leakage and inflammation in the lungs, most often as a result of pneumonia or sepsis, and there are around 300,000 annual cases in Europe and the US alone.
Shares were broadly flat at 825p on Monday morning.