Promising drug now moves into Phase II clinical trials
Research led by Jonathan Vennerstrom, Ph.D., professor in the University of Nebraska Medical Center College of Pharmacy, has led to the discovery of a single-dose oral antimalarial drug candidate.
The discovery of the drug, known as OZ439, was reported in the current edition of the science journal PNAS (Proceedings of the National Academy of Sciences). In Phase I clinical trials, the drug candidate was well-tolerated in doses up to 1,600 mg.
The drug is now being tested in Phase II trials in hundreds of malaria patients to determine the effective dose.
“A new single-dose drug would be a significant advance,” Dr. Vennerstrom said. “We all forget to take our medications from time to time, so compliance becomes much easier when you have a single-dose drug.”
In comparison, OZ277, the first-generation drug candidate, requires three consecutive daily doses. OZ277 is currently in Phase III clinical trials with the Indian pharmaceutical company, Ranbaxy, Ltd.
Dr. Vennerstrom said the half-life of OZ439 in the blood stream is about 10 times what has been seen with OZ277.
In addition, Dr. Vennerstrom said the cost of manufacturing OZ439 should be nearly half that of OZ277.
The World Health Organization estimates that malaria kills more than 2 million people each year in places such as Africa, Asia, Central and South America. In addition, an estimated 300 million to 500 million new cases of malaria are diagnosed each year. More than 90 percent of all malaria cases occur in Africa.
The UNMC project is funded by Medicines for Malaria Venture (MMV), a nonprofit organization based in Geneva, Switzerland which receives 60 percent of its funding from the Bill and Melinda Gates Foundation.
Other team members working with Dr. Vennerstrom on this global initiative come from Monash University in Australia and the Swiss Tropical Institute in Basel, Switzerland.
Through world-class research and patient care, UNMC generates breakthroughs that make life better for people throughout Nebraska and beyond. Its education programs train more health professionals than any other institution in the state. Learn more at unmc.edu.