Island Pharmaceuticals Ltd (ASX:ILA), an Australian mid-clinical stage antiviral drug development company, has submitted an Investigational New Drug (IND) application for the ISLA-101 Phase 2a PEACH clinical trial.
ISLA-101 is a well-known drug candidate that is being repurposed for the prevention and treatment of dengue fever and other mosquito (or vector) borne diseases.
The IND application has been filed with the United States Food and Drug Administration (US FDA).
“Major milestone”
Island’s CEO and managing director Dr David Foster said, “After a focused effort, we are delighted to achieve this major milestone of submitting our IND to the FDA.
"This submission follows the recent Institutional Review Board (IRB) approval for our Phase 2a PEACH clinical trial in dengue fever, and IND clearance will be the final, critical step before we can begin the trial.”
Dr David Foster.
About dengue fever
Dengue fever is a viral infection transmitted to humans through the bite of infected mosquitoes, with severe cases leading to serious illness and death.
The number of dengue cases reported to the World Health Organisation (WHO) has increased more than eight-fold over the last two decades, with one modelling estimate indicating there are now 390 million dengue virus infections per year.
PEACH study
An IND application is a request from a clinical study sponsor to obtain authorisation from the FDA to administer an investigational drug or biological product to humans.
Island is the sponsor for the PEACH study, which is a Phase 2a randomized, double-blind, placebo-controlled study for the Prophylactic Examination of an Antiviral in a Dengue Challenge model.
Once the IND is submitted, Island must wait 30 calendar days before initiating any clinical trials.
During this time, the FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.
Presuming the IND is cleared by the US FDA in around 30 days, Island’s PEACH clinical trial could begin screening and enrolling subjects in January 2023.
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 certain other criteria are met, Island may be eligible to obtain a 'Priority Review Voucher' (PRV) at the time of FDA approval.
This means that as well as getting approval to manufacture and sell ISLA-101, the PRV could permit Island to expedite the FDA approval process for a new drug or sell the PRV in a secondary market.