Zydus Cadila completes phase I trials of ZY19489A, single-dose cure for Malaria

Zydus Cadila has announced that its antimalarial compound ZY19489 (MMV253) in collaboration with a Swiss-based product development partnership Medicines for Malaria Venture (MMV) has now completed Phase I clinical evaluation [registration number-ACTRN12619000127101].

In the first study done on humans, which was conducted in Australia, escalating doses of 25 to 1,500 mg were administered to healthy human volunteers. Emerging pharmacokinetic (PK) and safety data were evaluated by a safety data review committee. 

In addition, a malaria challenge trial involving the Plasmodium falciparum volunteer infection study (VIS) model was also conducted in Australia to determine the safety & tolerability and to characterise the antimalarial activity of a single-dose oral administration of ZY-19489 in healthy adult volunteers [registration number-ACTRN12619001215112]. No serious or severe drug-related adverse events were observed. 

ZY19489 has the potential to be a single-dose cure for Plasmodium falciparum and Plasmodium vivax malaria due to its novel mechanism of action, rapid parasites killing activity across all intra-erythrocytic malaria stages, low resistance potential, and long half-life. 

Artemisinin resistance is seen as a mounting challenge to the global fight against malaria. ZY19489 is being developed to provide an effective alternative to the current front-line antimalarial drugs for the treatment of P. falciparum and P. Vivax malaria, as artemisinin-based combination therapies (ACTs) are under threat of resistance. 

As per the World Malaria Report 2020, in 2019, there were an estimated 229 million cases of malaria worldwide while the estimated number of malaria deaths stood at 4,09,000. 

During Thursday’s early morning trading session, the stock of Cadila Healthcare was trading 1 per cent higher at Rs 482.55 from its previous close of Rs 478.15 on BSE.