ISLA-101: A clinical-stage antiviral targeting dengue and beyond

ISLA-101: A clinical-stage antiviral targeting dengue and beyond

Demonstrated activity across multiple flaviviruses with a strong human safety profile and Phase 2 clinical progress

ISLA-101 is a clinical-stage antiviral therapy being developed for the prevention and treatment of dengue fever and other mosquito-borne diseases.

48+

Clinical Studies

2a

PHASE 2A PROTECT STUDY COMPLETED

4

Dengue Serotypes Targeted

DEMONSTRATED PROPHYLACTIC AND THERAPEUTIC EFFICACY IN HUMAN CLINICAL TRIALS

Key highlights

  • ISLA-101 has demonstrated broad anti-viral activity in in-vitro models
  • Demonstrated potent anti dengue-1 activity in in-vitro models using fresh human cells
  • Protective in dengue fever and Zika in animal models
  • Shown to prevent death in 70% of subjects in extremely lethal animal models
  • Increasing concentrations of ISLA-101 prevent death induced by an otherwise lethal dengue fever infection
  • 48 human clinical studies completed in other indications
  • Demonstrated efficacy in prophylactic and treatment cohorts in Phase 2a PROTECT clinical trial

What is ISLA-101

ISLA-101 is a clinical-stage antiviral therapy being developed for the prevention and treatment of dengue fever and other mosquito-borne diseases. As a small molecule antiviral, it has demonstrated activity across all four dengue serotypes, as well as other related viruses such as Zika.
The program has progressed through a Phase 2a/b clinical trial in dengue-infected subjects, supporting its potential as both a preventative and therapeutic option in a disease area with significant unmet need.

Broad Antiviral Activity

ISLA-101 has demonstrated broad antiviral activity in in-vitro models, including against flaviviruses — a subgroup of arboviruses responsible for diseases such as dengue and Zika.

In laboratory studies using fresh human cells, the compound has shown potent activity against dengue-1, reinforcing its relevance in targeting clinically significant viral strains.

Preclinical Efficacy

In animal models, ISLA-101 has demonstrated protective effects against both dengue fever and Zika virus infection.
In highly lethal dengue models, the drug has been shown to prevent death in up to 70% of subjects, with increasing concentrations correlating with improved survival outcomes. These results highlight its potential to meaningfully impact disease progression in severe infections.

Clinical Development and Safety

ISLA-101 benefits from a well-established safety profile, supported by 48 completed human clinical studies across other indications. This extensive body of work has confirmed the drug’s safety and tolerability in humans, as assessed by multiple regulatory authorities.

Island’s own Single Ascending Dose study and subsequent modelling have further reinforced these findings, while also helping to define appropriate dosing strategies for Phase 2 clinical development.

Addressing a Significant Global Need

Dengue fever represents a major and growing global health challenge, with an estimated 400 million infections each year. A large proportion of cases are asymptomatic, enabling continued transmission within communities.

The spread of mosquito-borne viruses is accelerating due to climate change, increasing their presence across regions including the Americas, Africa, the Middle East, Asia, Europe and the Pacific.

A Differentiated Treatment Opportunity

There are currently limited pharmaceutical treatment options available for dengue, and existing vaccines are restricted to a narrow population. ISLA-101 has been repurposed as an oral antiviral therapy designed to address this gap.

The ongoing clinical strategy incorporates both prophylactic and therapeutic approaches, with studies designed to evaluate its potential to prevent infection as well as treat active disease.
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