Island Pharmaceuticals Ltd (ASX:ILA) has formally filed its response to the United States Food and Drug Administration (FDA) after a review of all aspects of the company’s original Investigational New Drug (IND) submission for ISLA-101.
The antiviral drug development company’s lead asset ISLA-101 is being repurposed for the prevention and treatment of dengue fever and other mosquito (or vector) borne diseases.
On February 1, 2023, ILA received detailed feedback from the FDA on IND submission for the ISLA-101 Phase 2a clinical study.
The FDA confirmed that Island’s IND had been placed on clinical hold and clarified that the company’s protocol and application needed to be modified to advance the program. ILA was also required to provide further to support the proposed dosing regimen.
Read: Island Pharmaceuticals "appreciates" detailed FDA feedback on IND application
ILA has now completed a major body of work in drafting the protocol for the Single Ascending Dose study.
Note if ISLA-101 achieves FDA approval, and certain other criteria are met, Island may be eligible to obtain a 'Priority Review Voucher' at the time of FDA approval, which would not only give it approval to manufacture and sell ISLA-101 but could also allow Island to expedite the FDA approval process for a new drug or sell the PRV in a secondary market.
Support partners identified
ILA has identified partners to support the study, including a Clinical Research Organisation that can run it and an analytical laboratory to test and analyse blood samples collected.
The company has also pinpointed an Australian site where the study can take place.
With access to pharmacokinetics and regulatory affairs expertise expanded, ILA believes future responses will meet the FDA requirements in order to proceed.
“We have moved as quickly as possible to file this response with the FDA to address Clinical Hold items. As a next step, we will turn to navigating the remaining Non-Clinical Hold issues raised in the original feedback to our IND submission,” Island’s CEO and managing director Dr David Foster said.
“There remains a strong unmet need for dengue fever therapeutics. The Island team is dedicated to bringing ISLA-101 forward for the treatment of dengue fever and looks forward to updating the market as soon as possible.”
The FDA will now review Island’s response over the next 30 days.