When the disease struck then, most of the afflicted who died were children in sub-Saharan Africa. They died in part because past drugs are proving less effective as time goes on. The parasites which cause malaria are rapidly evolving and have become far more drug-resistant.
The Phase 1 clinical trial is being sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), a division of the (U.S.) National Institute of Health (NIH). The trial will take place at the Duke University School of Medicine in Durham, North Carolina.
According to the NIH, the new drug, which goes by the designation DM1157, was invented at Portland State University, then developed further by DesignMedix. Both organizations are based in Portland, Oregon.
The NIH says the investigational drug has been modified from the existing antimalarial drug chloroquine. According to a release from the NIH describing the study, “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.” The release goes on to say that, “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 phase 1 study has the primary goal of determining how the amount of food individuals are eating affects the effectiveness of the drug.
To do that, Duke is looking for up to 104 healthy individuals between 18 and 45 years old. Those individuals will be broken into three groups.
The first of those groups will have 56 volunteers in it. They will be asked to fast overnight and then in the morning receive either a dose of DM1157 at one of seven dosage levels (between 9 mg and 900 mg) or just a placebo.
The second group will also fast overnight and in the morning receive a first dose of either 150, 300, 6000 or 900 mg of the investigative drug, or a placebo. This group, which will have only 40 volunteers, will repeat this process for two additional days in a row.
A third group will first eat a high-fat meal, then be given either a single 300 mg dose of the drug or a placebo. Only 8 volunteers will be in this group.