Faron Pharma (LON:FARN) thinks its Traumakine drug still has the potential to treat around a third of acute respiratory distress syndrome (ARDS) patients in Europe and North America.
ARDS is a life-threatening ailment caused by an inflammation of the lungs that usually coincides with illnesses such as pneumonia or severe flu.
READ: Faron’s follow-up investigations may breathe new life into Traumakine
A phase III trial of Traumakine earlier this year yielded disappointing results and suggested the drug was not much better than a placebo with no medical benefit.
The results left Faron bosses scratching their heads, but convinced by the treatment’s potential, they have been extensively examining the data to find a way to progress the drug through to approval.
Scientists now believe they have the answer and it involves a special type of genetic mutation called a C/T mutation, which is carried by around one in three ARDS patient in Europe and North America.
In the phase III study, patients with this mutation and who received Traumakine were almost six times more likely to survive than those who were also taking the drug but didn’t have the mutation.
One of the reasons Faron thinks it is on to something is that no similar survival effect was seen in the placebo group.
In talks with regulators
Armed with this new data, Faron will now liaise with European and US regulators to figure out the next best step for the drug.
“We have, and are continuing to build, a solid body of evidence which indicates that there is clearly a subgroup of patients for whom Traumakine treatment could potentially be very effective,” said Faron chief executive Markku Jalkanen.
“The identification of these C/T patients is very easy with PCR-based analysis of a patient's DNA sample and provides a way to target this precise group of ARDS patients, representing around one third of all ARDS patients.
He added: “This finding has also allowed us to build further intellectual property for Traumakine as this association has not been previously reported. This protection has been filed and, if approved, could extend beyond 2040.”