One of the theories behind Faron Pharmaceuticals’ (FARN:AIM) shocking trial failure earlier this week is that an active version of its Traumakine drug may not have been administered to patients.
Shares in Faron plummeted over 80% following its Phase III trial failure on Tuesday.
‘If no Traumakine was delivered, then the INTEREST trial didn’t show that Traumakine didn’t work as the active drug wasn’t tested,’ comments Panmure Gordon’s Dr Julie Simmonds.
The speculation has emerged after Faron said its Traumakine treatment did not produce expected activity seen in previous trials based on early analysis of biomarker indicators.
The company says it is too early to understand why based on early analysis, although the potential causes could include formulation, administration and deactivation.
Simmonds says if Faron can find a legitimate reason for the non-delivery/inactivity of the drug, the underlying potential of Traumakine would be unchanged.
Traumakine aims to treat patients with severe orphan disease Acute Respiratory Disease Syndrome (ARDS), which currently has no approved pharmacological treatment.
Symptoms of ARDS include widespread capillary leakage and inflammation in the lungs after pneumonia, sepsis or significant trauma.
The biopharma company needs to find out what went wrong before determining the next steps as it prepares to undertake further analysis of its data.
A key factor determining what happens next is an ongoing Japanese clinical trial, due to read out in the third quarter of 2018. Even if this is successful, at least one more trial is necessary before Traumakine can reach the market.
