Zydus Cadila completes Phase 1 trails for its antimalaria compound

Zydus Cadila announced that its antimalarial compound ZY19489 (MMV253) in development with Swiss-based product development partnership Medicines for Malaria Venture (MMV) has now completed Phase I clinical evaluation [Reg'n Number ACTRN12619000127101]. In the first in humans study conducted in Australia, escalating doses of 25 to 1500 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 P. falciparum volunteer infection study (VIS) model was also conducted in Australia to determine the safety and tolerability and to characterize the antimalarial activity of a single-dose oral administration of ZY-19489 in healthy adult volunteers [Reg'n Number ACTRN12619001215112]. No serious or severe drug-related adverse events were observed.

 

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

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