Zydus receives approval to conduct Phase III trials of Zintrodiazine for malaria in India
Two studies to evaluate efficacy and safety in Plasmodium falciparum and Plasmodium vivax infections
Zydus Lifesciences announced that it has received permission to conduct two Phase III clinical trials of Zintrodiazine in patients with uncomplicated malaria caused by Plasmodium falciparum (P. falciparum) and Plasmodium vivax in India.
Both Phase III trials will be multi-centre, randomised, assessor-blind, active-comparator studies to determine the efficacy, safety and tolerability of orally administered Zintrodiazine in patients with uncomplicated malaria due to P. falciparum and P. vivax.
The first Phase III clinical trial will be conducted in 651 patients with uncomplicated malaria due to P. falciparum. The primary objective is to evaluate the efficacy of Zintrodiazine as measured by PCR-adjusted adequate clinical and parasitological response (ACPR).
The second Phase III clinical trial will be conducted in 390 patients with uncomplicated malaria due to P. vivax mono-infection. The primary objective is to evaluate the efficacy of Zintrodiazine as measured by ACPR.
Secondary endpoints in both clinical trials will include the incidence of recrudescence, defined as the return of malaria symptoms and parasites in the blood due to incomplete clearance of the original infection, as well as new infections, parasite clearance time and fever clearance time.
Speaking on the development, Dr Sharvil Patel, Managing Director, Zydus Lifesciences, said, “Our journey of innovation has always been about advancing science to address unmet healthcare needs. Malaria remains a significant health concern affecting people of all ages. The approval to begin Phase III trials for Zintrodiazine marks a critical milestone in the fight against malaria. With increasing resistance to current therapies, we are committed to developing an effective treatment to address this challenge.”