Ten years ago, Portland State University chemistry professor David Peyton was troubled by news that the malaria drug Chloroquine was becoming less effective.
So he worked with his students to brainstorm possible fixes and then attended a tropical medicine conference in Miami.
“On the way back, on the plane, I sketched out the first design of the molecules that eventually became DM11-57,” he said.
That’s the name the lab uses for the drug. DM11-57 works by helping Chloroquine do its job.
Chloroquine was becoming less effective because malaria parasites had mutated to expel it. On a very basic level, Peyton added a new molecule to Chloroquine that prevented that.
“It worked even better than Chloroquine, so we knew at that point that we were really on to something,” he said.
Malaria is spread by mosquitoes, which can pass along the parasite that carries the disease.
More than 300 million people suffer from malaria each year. One million die, mostly children and mostly in Sub-Saharan Africa. It’s a population that usually lacks health insurance or the money to make a drug profitable — and thus more appealing to drug companies to manufacture and sell.
Peyton didn't know the first thing about developing a drug without a financial market when he started his malaria work, so he joined forces with Sandra Shotwell, and they formed the drug development company DesignMedix.
Shotwell, the CEO of the new company, said the first thing they did was set up a licensing agreement with PSU.
“And as part of the license agreement, Portland State University got a piece of equity in the company,” she said.
But that didn’t solve the problem of making DM11-57 profitable.
“Congress put in place a program to provide an incentive to people to develop drugs for neglected diseases like tropical medicines,” Shotwell said.
The incentive is called a "Tropical Disease Priority Review Voucher" — essentially a golden ticket that speeds the regulatory process for drugs aimed at solving diseases that impact some of the poorest parts of the world.
It allows the holder to essentially jump to the front of the line of the FDA drug approval process. And that kind of jump can be worth a lot of money to a big drug manufacturer seeking rapid review of its latest blockbuster product.
“Those vouchers are tradeable, and they’ve been sold for up to $350 million dollars. So that’s really a commercial incentive to try to encourage this kind of product development,” Shotwell said.
DM11-57 has already been tested in animals and is now in human trials with healthy volunteers.
“The question is, does it get absorbed into the body? Does it cause some side effects?" Shotwell said. "That’ll take about another year and a half."
After that, the drug would be tested in about 150 patients in West Africa.
Duke Clinical Research Institute in North Carolina is conducting the human trials to ensure no bias is introduced by the drug developers. The National Institutes of Health is interested enough that it's paying for those tests.
The entire effort is being driven by Oregonians. The molecule was discovered at PSU and Cascade Chemistry out of Eugene made the active pharmaceutical ingredient. A Bend company, Serán Bioscience, also made the capsules for the pills.
Still, it’s very early in the process. So far, investors have spent about $10 million. That includes private investment and government grants, including from the state of Oregon. Millions more — and several more years of research — are ahead before the drug reaches market.
Roland Cooper, a researcher with Dominican University Of California, has tested scores of new antimalarial drugs in his Uganda lab.
“DM11-57 is really quite remarkable," said Cooper, who has no financial interest in the drug. "It’s got very high potency and it really never changes, which is a great characteristic of an anti-malarial drug.”
“This one may have a pretty good chance. But to me, 20 percent is a pretty good chance."