GSK and Medicines for Malaria Venture (MMV) today presented positive data from the TEACH study of tafenoquine, an 8-aminoquinoline, for the prevention of relapse (radical cure) of Plasmodium vivax (P. vivax) malaria in children and adolescents.
TEACH evaluated dosages of tafenoquine based on weight in children and adolescents between the age of 6 months and up to 15 years. The safety profile was consistent with previous clinical studies with the exception of early post-dose vomiting. Ninety-five percent of the study’s 60 subjects had no recurrence of P. vivax malaria during four months of follow-up.
The current standard of care for prevention of P. vivax relapse requires a 7- or 14-day course of treatment and at present there is no age-specific paediatric formulation. Tafenoquine is a single dose treatment for radical cure and is already licensed in people aged 16 and older. TEACH investigated the use of a novel 50 mg dispersible tablet, which was developed to facilitate use in children. The study also used the approved 150 mg tablet.
Pauline Williams, Head of Global Health R&D, GSK, said: “The results presented today represent an encouraging step forward in the fight against P. vivax malaria in children, providing evidence to support a paediatric formulation of tafenoquine. Poor compliance with the current standard of care can allow P. vivax malaria to relapse from its dormant stage, causing terrible suffering in the young people disproportionately affected by the disease and enabling ongoing malaria transmission, undermining malaria elimination efforts. These data underscore GSK’s dedication to combatting infectious disease, especially in children, and our commitment to discover and develop interventions to tackle malaria.”
David Reddy, MMV’s Chief Executive Officer, said, “Children are particularly at risk of P. vivax malaria infections, which is why the development of a paediatric formulation of tafenoquine was critical. At MMV we aim to deliver treatments for the most vulnerable populations, and are proud to have worked together with GSK to meet this unmet need with a single-dose treatment for the prevention of relapse for children from 6 months of age.”