Melbourne-based antiviral drug development company Island Pharmaceuticals (ASX:ILA) has updated investors on its ISLA-101 clinical program in dengue fever.
The company said it had revised a conical trial protocol for a US-based Phase 2a/b study of ISLA-101. Under the FDA-cleared revision, the trial has been renamed PROTECT and will now have two cohorts.
The first cohort is a Phase 2A preventative arm under which participants will be randomised to ISLA-101 or placebo. Participants will be randomly assigned to active or placebo in the second therapeutic arm.
The company said that as part of the consultation, the FDA requested that it wait to start infecting subjects until the end of mosquito season, which occurs on 1 October. This is designed to ensure that the public is protected from unwanted transmission of the virus by mosquitoes.
Dengue is a flu-like illness caused by a mosquito-transmitted virus. It is estimated to affect up to 400 million people worldwide annually.
The study will be funded via a US Congressionally-directed Medical Research Programs grant
Island's CEO and managing director, Dr David Foster, said, "We are very pleased to have now locked down our protocol for the ISLA-101 PROTECT study and have it registered, in preparation for final ethics approvals.
"We have worked hard to bolster our internal capabilities and as a result have not needed to engage a CRO [clinical research organisation ] for this study. This strategy not only has streamlined efforts on protocol revisions, FDA communications and trial execution, but has substantially reduced costs enabling us to complete the Phase 2a, prophylactic cohort of the PROTECT study with existing funds.”
