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SII and DNDi to Run International Phase III Trial of Dengue Monoclonal Antibody

The study will test whether the antibody can stop cases from progressing to severe dengue and address a decades‑long lack of post‑infection treatments.

Representational photo. | Dengue-infected patients receive treatment inside a dengue ward at a hospital in Uttar Pradesh. | ANI

Overview

  • SII has signed an agreement with DNDi to support an international Phase III trial of the antibody formerly called VIS513, with DNDi leading research in Brazil, Malaysia and Thailand and SII providing the drug, manufacture and refrigerated transport.
  • The trial is planned to enroll about 1,000 participants beginning in early 2027 while a separate Phase III study of the same antibody continues in India.
  • The antibody is a laboratory-made protein designed to bind the dengue virus, block viral replication and reduce the chance that infected patients will develop severe dengue.
  • Dengue currently has no approved antiviral treatment after infection and caused more than 14.4 million reported cases and over 11,000 deaths in 2024, which raises the stakes for a therapy that could ease pressure on hospitals and public health systems.
  • Funding and partnership details include research collaborators such as Fiocruz and Mahidol’s Siriraj Hospital and external funders named for trial support, but DNDi and SII have not set a timeline for regulatory approval or confirmed final pricing and access plans.