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Portland Business Journal: NIH grant propels PSU biotech spinoff to clinical trial
Author: Elizabeth Hayes, Portland Business Journal
Posted: April 17, 2017

Read the original article in the Portland Business Journal here.

DesignMedix Inc., a Portland-based biotech company that is developing a cure for malaria, announced this week that it had secured key support from the National Institutes of Health for an early phase clinical trial.

NIH awards millions of dollars in research grants each year. NIH agreed to sponsor the phase 1 clinical trial for DesignMedix’s malaria drug at Duke Clinical Research Institute later this year.

“They will cover all the costs in the approach to the FDA; they’ll be the official group sponsoring it,” said David Peyton, DesignMedix’s chief scientific officer. “That really helps. That’s one reason we were happy to go this route.”

The other reason is that it should speed up the process by a year, Peyton said.

“It’s much faster than grant writing,” he said. “Time equals delays equals loss of resources to investors.”

Peyton and his colleagues developed the anti-parasite drug at PSU, where he teaches in the Department of Chemistry. He, Lynnor Stevenson and Sandra Shotwell, who is currently CEO, founded the company in 2008 to move the early stage idea into a commercial product. They hope to serve the worldwide demand for malaria drugs. Around 600,000 children under the age of five die of malaria each year.

The company, which exclusively licensed the drug from PSU, is housed at the PSU Business Accelerator.

“It’s excellent validation to have NIH support the trial,” Shotwell said.

Phase 1 trials test human safety. The drug will be given in small doses to human volunteers. Previously, it has been tested only in animals and blood samples given by 150 infected patients from Africa and Asia.

The drug, called DM 1157, counteracts drug resistance, the problem with the leading malarial drug, chloroquine.

“What I did was I took chloroquine and said, let’s make it good again,” Peyton said. “It doesn’t get kicked out from the stomach of the parasite. It’s taken us back to 1945 and is giving us a shot at taking the best drug we ever had against malaria and giving it another try, so we don’t have to lose it to drug resistance.”

If the phase 1 trial goes well, DM 1157 will move to a clinical setting, most likely in Africa and/or Southeast Asia to evaluate the curative effect. Then comes phase 3, a large-scale, multi-center, multi-country trial. The whole process is expected to take about four or five years.

Peyton is predicting the drug will be a three-dose cure. He is also evaluating other antimalarial drugs that are in development to see what could be combined with DM 1157.

In addition to the clinical trial agreement, NIH has given DesignMedix around $9 million in grants over the years. The company has also raised just over $3 million from angel investors, Shotwell said.

Photo: David Peyton, courtesy of DesignMedix, Inc.