How Ebola Drug Trials Today Could Shape Future Drug Development
Frank Vinluan 12/9/14
Ebola research has yet to yield a proven vaccine or antiviral drug but the work done so far could be paving the way for something else—faster and more efficient ways of testing drug candidates for other diseases.
Jeffrey Spaeder, chief medical officer for Durham, NC, contract research organization Quintiles (NYSE: Q), says the current Ebola outbreak has placed urgency on a drug development process that typically requires years of testing to determine safety and efficacy. But he says urgency also leads life science companies, non-profit organizations, and government bodies to work together in new ways.
“I never want to look at a catastrophe like this as having something good about it but we are learning things, potentially, about accelerating drug development, working in collaborations,” Spaeder says. “Can we take lessons learned from this, and apply it, not only for the other infectious diseases that affect the emerging world, but [also] other significant global healthcare burdens?”
Spaeder was one of the speakers Monday at Ebola NC: Local Response, Global Impact, which featured researchers, clinicians, and public health officials. The nonprofit Triangle Global Health Consortium and the North Carolina Biotechnology Center jointly coordinated and hosted the conference.
Quintiles, which runs clinical trials among other services it provides to pharmaceutical companies, has done work for companies developing and testing Ebola drugs and vaccines but the company does not disclose its clients. Spaeder, a cardiologist, says Ebola presents several challenges for drug trials. The disease is rare, and therefore, medical expertise in Ebola is also rare. That makes it difficult to find the medical professionals qualified to conduct Ebola clinical trials. The treatment setting can also introduce a bias into the studies that factors into the trial results. While mortality rates for the current Ebola outbreak are around 70 percent, patients who have been treated in the United States have fared much better. That makes it hard to assess whether the patient is responding to a particular medical intervention or the standard of care.
Two Durham companies, BioCryst (NASDAQ: BCRX) and Chimerix (NASDAQ: CMRX), are moving forward on tests of antiviral drug candidates. BioCryst’s antiviral has shown activity against Ebola in laboratory tests, and is now being tested in animals. Chimerix’s antiviral is starting a Phase 2 trial in Ebola—it’s gotten this far so quickly because Chimerix has already taken the drug candidate to Phase 3 clinical trials targeting a different virus, adenovirus. That means Chimerix already has plenty of data about the drug’s safety in patients.
But the progress toward an Ebola treatment trials raises the question of how to test these drugs in patients. Randomized controlled clinical trials are the gold standard by which drugs are tested for efficacy. But drugs for deadly diseases, such as Ebola, are not always tested in this manner. Some ethicists say denying a test group of patients even an experimental drug for such a deadly disease would be wrong. Michelle Berrey, Chimerix’s CEO, suggests an alternative approach where all test groups receive drugs in a comparative trial. If the mortality rate improves in one group receiving a particular drug, patients could be shifted to that group.
“You minimize the number of individuals who are exposed to a less than efficacious agent,” Berrey says. “So there are some ways to conduct these trials without having necessarily a placebo control.”
These so-called adaptive clinical trials aren’t unique to Ebola drug testing. But pharma companies and CROs have been pursuing more of these kinds of trials, saying that the ability to make changes and adjust as safety and efficacy data become available, speeds up the clinical testing process.
GlaxoSmithKline (NYSE: GSK), which earlier this year started Phase 1 trials of its Ebola vaccine candidate in partnership with the National Institutes of Health, is already looking ahead toward Phase 3 trials. Donna Altenpohl, vice president of U.S. policy for GSK, says the pharma company is talking with the Food and Drug Administration, the European Medicines Agency, and the Bill and Melinda Gates Foundation about clinical trial models that would keep patients safe while also testing for efficacy. She says these approaches could be applied to trials of other drugs in other diseases.
“We don’t want it to always be a just in time situation, we want it to be sustainable,” Altenpohl says. “When you have a more sustainable platform and a more predictable platform, it encourages people to invest in medical countermeasures.”
Frank Vinluan is a contributing editor at Xconomy, based in Research Triangle Park. You can reach him at fvinluan@xconomy.com
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