Island Pharmaceuticals Ltd (ASX:ILA) has received feedback from the US Food and Drug Administration (FDA) on its Investigational New Drug (IND) application for the ISLA-101 Phase 2a PEACH clinical trial.
The mid-clinical stage antiviral drug development company may be required to amend the study’s protocol and provide support for or modify the proposed dosing schedule.
The IND has been placed on ‘Clinical Hold’, with a formal letter to be issued by the FDA within the next 30 days.
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.
Working together
“We appreciate all feedback from the FDA on the trial, and will work quickly and constructively to address the Administration’s feedback,” Island chief executive officer and managing director Dr David Foster said.
“As soon as we have a material update, we look forward to sharing the next steps on the ISLA-101 program with the market.”
PEACH study
The 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 randomised, double-blind, placebo-controlled study for the Prophylactic Examination of an Antiviral in a Dengue Challenge model.
If ISLA-101 achieves FDA approval, and certain other criteria are met, Island may be eligible for a 'Priority Review Voucher' (PRV) at the time of approval.
This means that as well as 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.