Duke Unveils Stage 1 Clinical Trial of Malaria Drug

(CN) – Researchers announced Monday that they are enrolling human subjects for a new drug to treat malaria, which killed nearly half a million people, most of them children in sub-Saharan Africa, two years ago.

This colorized scanning electron micrograph depicts a red blood cell infected with malaria parasites, which are colorized in blue. To the left of the infected cell are uninfected cells with a smooth red surface. (Image credit: NIAID)

Several approved treatments for the mosquito-borne disease already exist, but the National Institutes of Health noted in a release this morning that the effectiveness of these drugs is diminishing as malaria-causing parasites become increasingly drug resistant.

Michael Cohen-Wolkowiez, a professor of pediatrics at the Duke Clinical Research Institute, is the principal investigator for the new investigational drug.

While the Phase 1 clinical trial will be conducted at the Duke University School of Medicine in Durham, North Carolina, it is being sponsored by the NIH subdivision known as the National Institute of Allergy and Infectious Diseases (NIAID).

DM1157, as the investigational drug is known, was invented at Portland State University and developed by DesignMedix, both based in Portland, Oregon.

The NIH described the drug as a modified form of the established antimalarial drug chloroquine.

“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,” a release from the NIH states. “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.”

Researchers are enrolling up to 104 healthy volunteers between the ages of 18 and 45 years old for the study, which they expect to complete by June 2019.

The largest of what will be three randomly apportioned groups in the study will involve a pool of 56 volunteers. They will fast overnight and then receive either a single dose of the experimental drug at one of seven dosage levels (9 mg through 900 mg) or a placebo.

A second group of 40 volunteers will also fast overnight and then receive either one dose containing 150, 300, 600 or 900 mg of DM1157, or a placebo. Group 2 will repeat this routine for two more consecutive days.

The third group will consist of just eight volunteers who will be given either a single 300-mg dose of the investigational drug or placebo after eating a high-fat meal.

This is meant to establish whether the investigational drug has different effects when taken with food.

Researchers will monitor all three groups for adverse effects throughout the trial, taking blood samples for at least five days after their last dose.

In 2016, according to data from the World Health Organization, there were an estimated 216 million new malaria cases and 445,000 deaths occurred, primarily among children living in sub-Saharan Africa.

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