Therapy Areas: AIDS & HIV
Human Trials Begin for DesignMedix Anti-Malarial Drug Developed to Overcome Growing Drug Resistance
12 September 2018 - - US-based small molecule drug developer DesignMedix's lead product, experimental anti-malaria medicine DM1157, has begun human clinical trials, the company said.

DM1157, discovered at Portland State University and developed by PSU spin-out DesignMedix, was designed to overcome the serious issue of growing drug resistance among malaria medicines.

"Existing malaria medicines are becoming less effective because of the rise in drug resistance in malaria parasites," said Sandra Shotwell, Ph.D., DesignMedix co-founder and CEO. "This new medicine is designed as a first line therapy to overcome drug resistance, and if approved could be used to treat ms of people worldwide, allowing many sickened with malaria to make a complete recovery."

The first cohort of human volunteers has been administered DM1157 at Duke Clinical Research Institute in North Carolina.

This Phase I study will assess the drug's safety and its ability to be absorbed in healthy human volunteers as a crucial first step toward gaining approval from the US Food and Drug Administration for subsequent testing in patients with malaria and, ultimately, for licensure for widespread domestic and international clinical use.

This clinical trial is being conducted with support from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, through contract HHSN272201500006I. The research has received ongoing funding from the NIH, as well as support from Medicines for Malaria Venture, the State of Oregon, and private investors.

Malaria sickens more than 200 m people every year and kills more than 400,000, mainly children under the age of five.

In Vietnam alone, more people have died from malaria in the last five years than in the 20 years of the Vietnam War, Shotwell said. Malaria also contributes to significant poverty in countries where the disease is endemic, causing weeks of incapacitating illness.

The technology underlying the drug's design was first developed in the laboratory of PSU chemistry professor David Peyton, Ph.D., DesignMedix's co-founder and chief scientific officer.

It was then exclusively licensed to DesignMedix. Peyton's original experiments centered on modifying chloroquine, a widely used malaria drug to which the malaria parasite had developed resistance, so that it no longer worked to cure the disease.

Armed with initial data and ongoing collaboration from the Peyton laboratory, DesignMedix led the commercial development of malaria drug DM1157.

Additional collaborators in Africa and Asia tested the drug on malaria parasites in blood samples drawn from patients, and found the drug killed the parasites in every sample, no matter how resistant they were to other drugs.

Researchers checked whether malaria parasites could become resistant to the drug and found that DM1157 remained effective even with extensive forced evolution of the malaria parasite.

For both DesignMedix and PSU, DM1157 is the first medication to reach this key development milestone of human clinical trials. The product has deep Oregon roots; it was invented at PSU, developed by DesignMedix in Portland, manufactured by Cascade Chemistry in Eugene, and formulated into capsules by Serán Bioscience in Bend.

DesignMedix was founded in 2008 to develop small molecule drugs to overcome drug resistance in treating infectious diseases.

This is the first DesignMedix product to reach clinical trials. DesignMedix is housed in the Portland State Business Accelerator, a leading technology incubator and home to more than two dozen dynamic science and technology startups.
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