Island completes phase 2b enrolments in dengue fever trial

All subjects enrolled in Island Pharmaceutical’s phase 2b arm of phase 2a/b PROTECT trial of ISLA-101 in dengue fever
Phase 2b study will explore ability of ISLA-101 to reduce symptoms of a person already infected with dengue virus
High-level results expected around April 2025 with full unblinded study results from phase 2a/b expected in Q4 FY25

Special Report: Australian antiviral drug development company Island Pharmaceuticals has completed enrolment of all subjects in the phase 2b arm of its ISLA-101 phase 2a/b PROTECT clinical trial in dengue fever.

Island Pharmaceuticals Ltd (ASX:ILA) said the phase 2 study is divided into two cohorts including a phase 2a prophylactic (preventative) and a phase 2b therapeutic (treatment) cohort.

In the phase 2a cohort the subjects were pre-treated with ISLA-101 before exposure to the challenge virus – an attenuated or weakened strain of dengue – to explore if ISLA-101 can prevent or reduce infection when administered prior to exposure to the virus.

Island said in the phase 2b cohort, the company was exploring if ISLA-101 can reduce virus levels and symptoms in an individual already infected with the dengue challenge virus.

Between the two studies, Island aims to understand if ISLA-101 can be an effective prophylactic and/or therapeutic against a dengue infection.

Exhibiting antiviral activity

Island progressed to the phase 2b cohort following the recommendation of the Safety Review Committee (SRC) after it reviewed data from the phase 2a cohort and determined that ISLA-101 was safe and exhibited antiviral activity.

Following submission of the SRC recommendation to the US Food and Drug Administration and allowing for a 30-day requested review period by the regulator, Island started enrolment of the phase 2b cohort earlier this month.

All 10 subjects in the phase 2b therapeutic arm have now been successfully enrolled.

‘Significant advancement’

Island’s managing director and CEO Dr David Foster said the company was pleased to have reached this important milestone in the PROTECT clinical trial.

Dengue fever is the most prevalent mosquito-borne viral disease and according to the World Health Organization the incidence of dengue has grown dramatically around the world in recent decades, with no specific treatment.

“The enrolment of the final six subjects in the phase 2b therapeutic arm is a significant advancement in our clinical trial and towards better understanding the potential of ISLA-101 as a treatment for dengue fever,” he said.

“High-level results from the phase 2b study are anticipated to be available around April 2025 with full results from the unblinded data of both the phase 2a and phase 2b cohorts expected in Q4 FY25.”

This article was developed in collaboration with Island Pharmaceuticals, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.