The world could soon be one step closer to a preventative for Dengue fever with Island Pharmaceuticals (ASX: ILA), an Australian antiviral drug development company obtaining Human Research Ethics Committee (HREC) approval to initiate its human trials for drug ISLA-101. 

This step of the regulatory approval framework is a significant step forward in the Company’s ambition to combat dengue fever, a mosquito-borne disease wreaking havoc in numerous countries worldwide.

Dengue fever, a severe viral illness transmitted by mosquitoes, poses a significant global health challenge. It is estimated that there are over 390 million dengue infections worldwide each year, with approximately 96 million of these cases showing clinical symptoms. Dengue fever is endemic in more than 100 countries, including regions where it was previously rare, such as Europe, where record cases have been reported. Additionally, major outbreaks have occurred in countries like Peru, Jamaica, and Bangladesh, underlining the urgent need for preventative and treatment options.

ISLA-101, a well-known drug candidate, is being repurposed by Island Pharmaceuticals for the prevention and treatment of dengue and other mosquito-borne diseases. The Single Ascending Dose study will involve administering increasing doses of ISLA-101 to three cohorts of healthy subjects. The primary objective of this study is to ensure that the administered doses can safely achieve the blood concentrations of ISLA-101 required to effectively combat the dengue virus.

Recruitment and dosing of subjects will commence shortly, with the final data expected in early 2024. The study will take place in Sydney.

Island Pharmaceuticals CEO, Dr. David Foster said, “Ethics approval was the final step in being able to commence our Single Ascending Dose study for ISLA-101, and we now look forward to recruiting and dosing our first subject shortly. 

“If all runs smoothly, our aim is to have final data by early 2024 and then rapidly transition to the Phase 2 PEACH study soon thereafter.”

This regulator milestone comes as a ray of hope for the millions affected by dengue fever and those living in high-risk areas. While the disease has been a longstanding concern in tropical and subtropical regions, its increasing global prevalence makes the development of effective treatments all the more critical.

In previous studies, ISLA-101 has been the subject of 48 Phase I and II human clinical trials. Those trials verified as safe in humans by multiple regulators but the drug has been unsuccessful in its original planned uses as either cancer or respiratory therapeutics. Pre-clinical work conducted at Monash University, however,  has demonstrated ISLA-101 to be promising as an antiviral drug.