Island Pharmaceuticals Ltd. provides an update regarding the ISLA-101 clinical trial product manufacturing campaign for the Company's Phase 2a clinical trial in dengue fever. Island announced that both ISLA-101 active and placebo clinical material for the upcoming PEACH clinical trial have been manufactured and are undergoing required final analysis and stability studies. Initial trial batches produced using historic methods yielded softgels with poor physical characteristics. As such Island determined that alternative shell formulations should be pursued. This involved revising the capsule composition such that it would deliver a superior quality product. Analytical results obtained from preliminary softgel batches prepared with the improved formulation were positive, giving Island confidence that the stability of the clinical batches will be successful. The process of reviewing and implementing the improved formulation led to a minor
extension to the manufacturing process timeframe. Importantly, at this stage, there is only expected to be a small impact on the overall trial schedule. The Investigational New Drug application submission is now expected to be filed in December 2022, with the trial opening in January 2023.