Island Pharmaceuticals (ASX:ILA) says it is now scheduled to file the final Single Ascending Dose Clinical Study Report from the recent clinical study with the US FDA.
Island said it will also file a proposed updated protocol for the coming ISLA-101 Phase 2 Clinical Study. The protocol revisions propose eliminating the originally planned dose escalation strategy in favour of a single dose level administered twice daily across multiple days. They also propose including a prophylactic and therapeutic arm instead of the previously proposed single prophylactic arm in the study.
CEO and managing director Dr David Foster said, “The team has put in a major effort to finalise both our data package for the Single Ascending Dose study and revised protocol for our upcoming Phase 2 study. Both are scheduled to be submitted for FDA review tomorrow, 3 July, US time. I am grateful to all involved. Given our investigational new drug application is open, and we have our clinical team and investigator lined up, once we have concluded the protocol amendment process, we plan to move quickly to commence our Phase 2 study in dengue fever.”