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Island Pharmaceuticals Ltd (ASX:ILA) has successfully enrolled its first subjects for a Phase 2b clinical trial to test the efficacy of drug ISLA-101 for the treatment of dengue fever.
Results from a Phase 2a trial – reported in November – had shown ISLA-101 to be both safe and demonstrating ‘anti-dengue activity,’ leading the Safety Review Committee (SRC) to recommend trialling move on to the next phase.
While Phase 2a has concentrated on ISLA-101’s preventative arm, with a clinical trial involving four subjects randomised as 3:1 (active: placebo), Phase 2b will focus more on the therapeutic features of the drug, with 10 subjects randomised 8:2 (active: placebo).
To date, four of these subjects have been enrolled, and the second group of six is now expected within the next two weeks.
During the trial, they will be exposed to an attenuated strain of the virus and then administered either the placebo or ISLA-101 seven days later.
Island will primarily be looking for evidence of viremia (virus load in the bloodstream) reduction in subjects, although other endpoints will include confirming the safety of ISLA-101, and a reduction in the symptoms associated with dengue infection.
CEO and managing director Dr David Foster said the assessment of the drug was moving along promptly.
“We are excited to start the Phase 2b cohort right on schedule, following the strong data
from our Phase 2a cohort and the subsequent recommendation by the SRC to move forward,” Mr Foster said.
“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.
“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.”
Island has been trading at 16 cents.
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