Island Pharmaceuticals starts phase 2b dengue trial

Island Pharmaceuticals commences phase 2b clinical trial of ISLA-101 in dengue fever
Progression to phase 2b cohort follows recommendation of the Safety Review Committee
High-level results from the phase 2b study are anticipated to be available around April 2025

Special Report: Australian antiviral drug development company Island Pharmaceuticals has kicked off the phase 2b clinical trial of lead drug ISLA-101 in dengue fever with the first subjects successfully enrolled.

Progression to the phase 2b cohort follows recommendation of the Safety Review Committee (SRC) after it reviewed positive data from the Island Pharmaceuticals (ASX:ILA) phase 2a trial, which demonstrated safety and anti-dengue activity.

Following submission of the SRC recommendation to the US Food and Drug Administration (FDA) and allowing for a 30-day FDA-requested review period, Island said it had now initiated the phase 2b cohort.

The phase 2a study examined the prophylactic (preventative) arm of ISLA-101 in dengue fever and involved four subjects with a 3:1 randomisation ration of (active treatment to placebo).

Phase 2b trial to study treatment effects of ISLA-101

Island said that the phase 2b therapeutic (treatment) arm of the trial would include 10 subjects with an 8:2 randomisation ratio of active treatment to placebo.

The first four subjects have already been enrolled, with the second group of six expected to enrol within the next two weeks.

Subjects in this treatment group will be given an attenuated strain of the dengue virus and, seven days later, will receive either a placebo or ISLA-101.

An attenuated strain refers to a weakened version of a virus, which has been modified to reduce its ability to cause illness.

Attenuated strains are often used in research or vaccines to stimulate an immune response or study the effects of a treatment without causing severe disease in participants.

The primary endpoint of the phase 2b study is viremia (virus load in the bloodstream) reduction in subjects.

Other endpoints include confirming the safety of ISLA-101 and a reduction in the symptoms associated with dengue infection.

High-level results from the phase 2b study are anticipated to be available around April 2025.

Hope for effective treatment for dengue fever

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

Island’s CEO and managing director Dr David Foster said the company was excited to start the phase 2b cohort right on schedule, following the strong data from its phase 2a cohort and the subsequent recommendation by the SRC to move forward.

“The SRC’s determination that there was evidence of antiviral activity in ISLA-101 treated subjects in the prophylactic setting was a landmark conclusion, and we look forward to seeing if ISLA-101 may also be effective as a treatment in dengue-infected subjects,” he said.

“After an incredibly fruitful 12 months for the ISLA-101 clinical program, we look forward to continuing the momentum and exploring our lead drug candidate as a dengue therapeutic through the Phase 2b study.”

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.