Island Pharmaceuticals Ltd (ASX:ILA) is progressing towards a Single Ascending Dose study for its lead asset, ISLA-101, with preparatory work largely complete and key agreements signed.
ISLA-101 is a well-known drug candidate that Island is repurposing for the prevention and treatment of dengue and other mosquito borne diseases.
With the Single Ascending Dose study slated to begin next month, Island has now appointed Beyond Drug Development as the Contract Research Organisation to run the study.
Through the same agreement, Scientia Clinical Research in Sydney has been appointed as the trial site for the study. Scientia Clinical Research is an FDA-audited early-phase clinical trials facility, with world-class clinical trial expertise and state-of-the-art facilities.
Under the agreement, Beyond is responsible for the conduct of the trial as well as engaging the clinical site, Scientia. It will be in charge of subject recruitment, clinical site operations, including housing of subjects during the trial, clinical operations, project management, data management and statistical analysis.
The Single Ascending Dose study
The Single Ascending Dose study is a dose escalation study, in which four cohorts of healthy subjects will receive escalating doses of ISLA-101. The aim of the study is to ensure that administered doses could safely achieve blood concentrations of ISLA-101 that are predicated to be effective against the dengue virus.
Subjects are expected to receive increasing doses of ISLA-101 under fasted conditions, with the cohort receiving the highest safe dose repeating the dosing under fed conditions. After each cohort, a Safety Review Committee will review safety data and determine if it is safe to move to the higher dose.
Island expects the study to commence next month, presuming it receives Hospital Research Ethics Committee approval, with dosing to be completed in late 2023, with read-out expected in early 2024.
As the study will be run in Australia, Island can make full use of the Research & Development Tax Incentive scheme, which offers rebates of up to 43.5% for each dollar spent on eligible research and development activities.
This study will form the basis for rapidly transitioning to Island’s planned Phase 2a human clinical dengue challenge clinical trial, called PEACH2 study.
Key appointments underpin the study
Island CEO and managing director Dr David Foster said, “We have been focused on moving the Single Ascending Dose study along as quickly as possible and are very pleased to be nearing the commencement point.
"Putting this agreement in place with Beyond as our [Contract Research Organisation] and naming Scientia as our clinical site are key to underpinning the study, with both organisations highly experienced in conducting studies like ours.
“Our focus now turns to pursuing ethics approval. Should all go to plan, we hope to see the first subject dosed in October, and dosing complete in this calendar year, with the study reading out in early 2024.”