Island Pharmaceuticals Ltd (ASX:ILA) has received Investigational New Drug (IND) clearance and the lift of a clinical hold for its ISLA-101 clinical program from the US Food and Drug Administration (FDA).
Island’s lead asset, ISLA-101, is being repurposed for the prevention and treatment of dengue fever and other mosquito (or vector) borne diseases.
Now that the clinical hold has been lifted, the company can proceed to conduct a single ascending dose study as requested by the FDA.
Island Pharma will engage the FDA in an open dialogue to help steer the study and the next steps of the drug’s development program.
IND clearance opens clinical pathway
“We are extremely pleased to have received Investigational New Drug application clearance from the FDA,” Island Pharmaceuticals CEO Dr David Foster said.
“With the clinical hold now lifted from the program, we can proceed with taking next steps to get ISLA-101 into the clinic via the Single Ascending Dose study.
“We anticipate being able to optimise and potentially streamline protocols for subsequent studies using input from the Single Ascending Dose study.
“Given this, we will seek opportunities to further engage with FDA to ensure we maximise all opportunities for adding value through efficient advancement of ISLA101 and better patient outcomes.”
The main data points ILA will focus on for the single ascending dose study will be blood concentration of ISLA-101 following administration.
The aim of the study – which will be held in Australia to take advantage of R&D tax credits – is to determine whether it is possible to safely administer doses that reach a blood concentration predicted to be effective against the dengue virus.