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Island Pharmaceuticals Completes Patient Dosing in Phase 2b PROTECT Trial for Dengue Fever Treatment

• Island Pharmaceuticals has successfully completed dosing of ten subjects in the Phase 2b treatment arm of the PROTECT trial, evaluating ISLA-101 for dengue fever treatment.

• The Phase 2b study aims to assess ISLA-101's ability to reduce viral load and symptoms in patients infected with an attenuated dengue virus strain, with results expected in April.

• The trial's advancement follows positive safety and anti-dengue activity data from the Phase 2a preventative arm, suggesting potential applications for both treatment and prevention of dengue fever.

Island Pharmaceuticals (ASX:ILA) has reached a significant milestone in its antiviral drug development program with the completion of subject dosing in the Phase 2b treatment arm of the PROTECT clinical trial, investigating ISLA-101 for dengue fever management.
The Phase 2b cohort, comprising ten subjects, received ISLA-101 according to schedule without any delays. This phase specifically evaluates the drug's therapeutic potential in subjects already infected with an attenuated dengue challenge virus, marking a crucial step in addressing this significant global health concern.

Trial Design and Objectives

The primary endpoint of the Phase 2b study focuses on measuring the reduction of viral load in patients' bloodstream. Secondary endpoints include comprehensive safety assessments of ISLA-101 and evaluation of its impact on dengue-associated symptoms. This treatment arm commenced enrollment in January following a favorable review of the Phase 2a data by the Safety Review Committee.

Previous Success in Phase 2a

The progression to Phase 2b was supported by encouraging results from the Phase 2a cohort, which investigated ISLA-101's preventative capabilities against dengue fever. The Safety Review Committee confirmed that key safety parameters and anti-dengue activity benchmarks were successfully met in the preventative arm, providing a strong foundation for the treatment phase.

Market Potential and Future Implications

Phil Lynch, Island's executive chairman, emphasized the significant market opportunity for ISLA-101. "The opportunity for Island is both significant in scale and increasingly positive," he stated. "The most recent 2a clinical results show the potential for a preventative approach to Dengue management that could aid millions of travellers who visit exposed countries, with malaria treatment a useful analogue to quantify this opportunity."
The company anticipates releasing high-level results from the Phase 2b study around April. These findings will be crucial in determining ISLA-101's potential as both a preventative and therapeutic option for dengue fever, addressing what Lynch describes as "a significant unmet consumer healthcare need."
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