Island Pharmaceuticals Ltd (ASX:ILA) has gained conditional approval from the Institutional Review Board to commence the Phase 2a PEACH clinical trial of its dengue prevention and treatment drug ISLA-101.
The PEACH study is a Phase 2a randomized, double-blind, placebo-controlled study for the prophylactic examination of an antiviral in a dengue challenge model, to be undertaken at SUNY Upstate University in New York.
Institutional Review Board approval in the United States is parallel to the Human Research Ethics Committee (HREC) approval in Australia.
The approval is subject to Island receiving the United States Food and Drug Administration’s (FDA) clearance for its Investigational New Drug (IND) application, which is expected to be filed before the end of the year.
Milestone checked
“We are delighted to have received this conditional approval for the ISLA-101 Phase 2a clinical trial,” Island’s chief executive officer and managing director Dr David Foster said.
“It is another important box that we have ticked in the lead-up to the start of the trial and one that puts us in good stead for once we have an open IND.”
Further announcements will be made nearer to the commencement of the trial.
About Island
Island is a mid-clinical-stage drug repurposing company focused on the topical area of antiviral therapeutics for infectious diseases.
Its lead asset is ISLA-101, a drug with a well-established safety profile, being repurposed for the prevention and treatment of dengue fever and other mosquito (or vector) borne diseases.
If ISLA-101 achieves FDA approval, and meets certain other criteria, Island may be eligible for a Priority Review Voucher (PRV). This means that on top of getting approval to manufacture and sell ISLA-101, the PRV permits Island to expedite the FDA approval process for a new drug or sell the PRV in a secondary market.