All 10 Subjects Enrolled in ISLA-101 Phase 2b Dengue Study
Island Pharmaceuticals has enrolled all subjects in the Phase 2b arm of its ISLA-101 dengue fever clinical trial, advancing its antiviral drug development with key results expected in 2025.
- All 10 subjects enrolled in Phase 2b therapeutic cohort of ISLA-101 trial
- Phase 2b study tests ISLA-101’s ability to reduce symptoms in infected patients
- Phase 2a cohort previously showed safety and antiviral activity
- High-level Phase 2b results expected by April 2025
- Full unblinded Phase 2a/b results anticipated in Q4 FY25
Trial Milestone Achieved
Island Pharmaceuticals Ltd (ASX: ILA) has announced the completion of enrolment for the Phase 2b therapeutic arm of its ISLA-101 clinical trial targeting dengue fever. This marks a significant step forward in the company’s efforts to develop an antiviral treatment for a disease that affects millions globally.
The Phase 2b cohort, comprising 10 subjects, is designed to evaluate ISLA-101’s efficacy in reducing viral load and symptoms in individuals already infected with the dengue virus. This follows the Phase 2a prophylactic arm, where subjects were pre-treated to assess the drug’s preventive potential.
Building on Positive Safety Data
The progression to Phase 2b was endorsed by the Safety Review Committee after reviewing Phase 2a data, which confirmed ISLA-101’s safety profile and demonstrated antiviral activity. This endorsement was subsequently submitted to the US FDA, which allowed the trial to proceed after a 30-day review period.
Island’s CEO, Dr David Foster, highlighted the importance of this milestone, emphasizing the company’s commitment to advancing clinical understanding of ISLA-101 as both a prophylactic and therapeutic agent against dengue fever.
Looking Ahead to Key Results
Investors and stakeholders can expect high-level results from the Phase 2b study around April 2025. These preliminary findings will provide early insights into the drug’s therapeutic potential. The full unblinded data from both Phase 2a and Phase 2b cohorts are scheduled for release in the fourth quarter of FY2025, which will offer a comprehensive view of ISLA-101’s efficacy and safety.
Island’s approach to repurposing ISLA-101, a drug with an established safety record, positions it uniquely in the antiviral space, particularly for vector-borne diseases like dengue. Success in these trials could pave the way for regulatory approval and potential Priority Review Voucher eligibility from the FDA, accelerating future drug development opportunities.
Strategic Implications
Completion of enrolment in Phase 2b not only advances Island’s clinical program but also signals growing momentum in the fight against dengue fever, a disease with limited treatment options. The coming months will be critical as the market awaits data that could validate ISLA-101’s role in both prevention and treatment.
Bottom Line?
With enrolment complete, Island Pharmaceuticals now shifts focus to pivotal data that could redefine dengue treatment.
Questions in the middle?
- Will ISLA-101 demonstrate significant symptom reduction in infected patients?
- How might FDA feedback influence the timeline for potential drug approval?
- Could the Priority Review Voucher materially impact Island’s future development pipeline?
