Trial of Anti-Malarial Drug Enrolling Subjects

"The increasing problem of drug resistance demands that we continue to find new and effective treatment options for malaria infection," said NIAID Director Dr. Anthony S. Fauci, M.D.

Enrollment has begun in a Phase 1 clinical trial to test the safety of a new investigational drug designed to treat malaria, as well as its effect on the human body, NIH announced Sept. 10, saying this first-in-human study is sponsored by the National Institute of Allergy and Infectious Diseases and is being conducted at the Duke University School of Medicine in Durham, N.C.

In 2016, an estimated 216 million new malaria cases and 445,000 deaths occurred, primarily among children living in sub-Saharan Africa, according to the World Health Organization. While several approved treatments for the mosquito-borne disease exist, increasing drug resistance among the malaria-causing parasites is diminishing their effectiveness, according to NIH.

"The increasing problem of drug resistance demands that we continue to find new and effective treatment options for malaria infection," said NIAID Director Dr. Anthony S. Fauci, M.D.

The study is led by principal investigator Dr. Michael Cohen-Wolkowiez, M.D., Ph.D., professor of pediatrics at the Duke Clinical Research Institute. It is testing an investigational drug called DM1157 that was invented at Portland State University and developed by DesignMedix, both based in Portland, Ore. The novel treatment is a modified form of chloroquine, an established antimalarial drug that kills malaria parasites once they have infected human red blood cells. Many strains of Plasmodium falciparum parasites, which cause the deadliest form of malaria, are now resistant to chloroquine, and the parasites can expel the drug before it can affect them. Like chloroquine, DM1157 interferes with the parasite's metabolism, but it also inhibits the parasite's ability to expel the drug. Results of earlier tests in animals suggest that DM1157 could have the same safety and efficacy as chloroquine.

The will enroll up to 104 healthy volunteers between the ages of 18 and 45 years old. The study is expected to be completed by June 2019.

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