Island Pharmaceuticals Limited (ASX:ILA)

Island Pharmaceuticals Limited has executed a Statement of Work (SOW) with Texas Biomedical Research Institute to advance the development of Galidesivir under the FDA's Animal Rule pathway. This collaboration represents the second phase of Island's dose optimisation program and aims to complement the ongoing studies with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). The Texas Biomed study will assess the efficacy of Galidesivir in non-human primates infected with the Angola strain of the Marburg virus, focusing on treatment initiation at the onset of clinical symptoms. Collectively, the studies are designed to generate critical pharmacokinetic and efficacy data to optimise dose selection and finalise the pivotal study design, reduce risks, and strengthen the regulatory package required for FDA discussions. The agreement also ensures access to additional animal cohorts, providing operational flexibility and maintaining development momentum toward pivotal Animal Rule studies.