Island Pharmaceuticals Ltd. announced that the Investigational New Drug (IND) application for the ISLA-101 Phase 2a PEACH clinical trial has been filed with the United States Food and Drug Administration (US FDA). 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. An Investigational New Drug application is a request from a clinical study sponsor to obtain authorisation from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.

Island Is the sponsor for the PEACH study, 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.