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Clinical Trial Testing Anti-Resistant Malaria Therapy

Malaria clinic

Malaria clinic in Mali (USAID.gov)

11 September 2018. A clinical trial is getting underway that tests the safety and dosage levels of a new drug to treat malaria and block resistance from developing to it. The drug, code-named DM1157, is made by DesignMedix Inc., a spin-off company from Portland State University in Oregon, where initial research on the drug was conducted.

Malaria, according to World Health Organization, affected 216 million people in 2016, which extracts heavy social and economic burdens in developing countries. In 2016, some 445,000 people died from malaria, of which 90 percent were in sub-Sahara Africa. Children under the age of 5 are particularly susceptible to the disease. The disease is caused by infections from the Plasmodium parasite transmitted by mosquitoes. In humans, the parasite multiplies in the liver, then infects red blood cells. Symptoms, including headache, fever, and vomiting, occur 10 to 15 days following transmission from a mosquito bite.

Chloroquine was an early and, until recent years, effective treatment for malaria, but the a number of parasite strains developed a resistance to chloroquine, making the drug ineffective in most parts of the world. DesignMedix licenses the research of David Peyton, a chemistry professor at Portland State, that founded the company in 2008, and where he continues as chief scientist. Peyton’s lab developed a technology that restores the potency of drugs against resistant pathogens, by designing hybrid forms of the old drugs with anti-resistant compounds bound to the original chemistry. The company applies the technology to create new drugs to treat infectious diseases where resistance develops to earlier therapies.

DM1157 is the company’s lead product, a modified form of chloroquine that builds in an agent interfering with Plasmodium’s metabolism like chloroquine, but also inhibits the parasite’s ability to expel the drug. National Institute of Allergy and Infectious Diseases, or NIAID, part of National Institutes of Health, supported the drug’s preclinical research and development through a Small Business Technology Transfer grant that continued through March 2018. Portland State received a U.S. patent for the technology applied to chloroquine-resistant malaria in November 2016, with Peyton listed as one of the two inventors.

“Existing malaria medicines are becoming less effective because of the rise in drug resistance in malaria parasites,” says Sandra Shotwell, DesignMedix’s co-founder and CEO in a joint university-company statement. “This new medicine is designed as a first line therapy to overcome drug resistance, and if approved could be used to treat millions of people worldwide, allowing many sickened with malaria to make a complete recovery.”

The early-stage clinical trial, sponsored by NIAID and conducted at Duke Clinical Research Institute in Durham, North Carolina, is recruiting 104 healthy participants to test the safety of DM1157 and its chemical activity in the body. Participants will be randomly divided into groups testing 7 dosage levels of DM1157, both single and multiple ascending dosage levels. Individuals in the trial will also be randomly assigned to fast before taking the drug or with food. The trial also includes participants assigned to receive a placebo.

The study team at Duke Clinical Research Institute is tracking participants’ vital signs like heart rate and temperature, as well as checking for irregular heart rhythms. Researchers are also watching for adverse effects and participants’ dropping out from the study. In addition, the team is measuring concentrations of DM1157 in the blood of participants and the time the drug stays in the blood stream before being cleared from the body.

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