The drug that was championed as USF’s Gatorade-like breakthrough in research came back last week with less-than-desirable results.
After USF researchers licensed an experimental type of antidepressant drug in 2009, the drug TC-5214 proved to show little effectiveness in comparison to placebo drugs in late-stage trials.
AstraZeneca PLC, the drug company that agreed to pay up to $1.24 billion for the drug in 2009, announced that the antidepressant did not perform as well as expected on the first of four such trials in the third phase of testing.
Share prices for Targacept, AstraZeneca’s partner company, dropped by 60 percent since the results of the study were announced, according to the Winston-Salem Journal, yet the president and CEO of Targacept, Don deBethizy, remains optimistic.
The company only needs two positive trial results to support the filing of a New Drug Application – the next step required before the drug hits the market – and will continue with the remaining trials of the third phase this year.
Research for the drug began in 1999 when a group of USF researchers were trying to create a drug to ease symptoms of Tourette’s syndrome, said Doug Shytle, one of the original researchers.
TC-5214 had no effect on Tourette’s, but the researchers found that the drug, which operated on nicotine receptors, alleviated the symptoms of patients suffering from depression.
Karen Holbrook, vice president of research and innovation, said the drug was anticipated to bring much success to USF.
“There is no idea on what kind of potential for (monetary) profit the drug has,” Holbrook said.
The drug’s main selling point was intended to be its minimal side effects, as opposed to other antidepressants, which may have side effects such as sexual dysfunction, nausea and chest pains.
“So far, there have been small side effects such as dizziness, constipation and headaches,” Holbrook said. “If this drug can maintain such a short list of side effects, it will benefit the school greatly.”
Earlier phases of testing for the drug came back with positive results for its effectiveness.
According to Targacept’s website, in February, the companies initiated a trial to assess the drug as a “switch” treatment for major depressive disorders, in which patients who did not respond favorably to other antidepressants were switched to a fixed dose of TC-5214.
The trial is still ongoing, but in 2009 Targacept conducted a similar study with results favoring TC-5214 as a “switch” drug.
Trials for the third phase of testing will continue, with researchers administering both fixed and flexible doses of the drug to the subjects.
Heather Savelle, Targacept senior director and investor of public relations and corporate communications, said to The Oracle in October that a long-term safety study for the drug should be released early next year.
Shytle said the results are long-awaited.
“It’s always rewarding when you put a lot of time and effort into something to finally get licensed,” he said. “This was the start of the long, arduous process to where we are now.”
The company’s website said the drug is still expected to hit the market in 2012, as it had originally intended.
Savelle and AstraZeneca Director of Brand Corporate Affairs Blair Hains could not be reached for comment after the announcement.
– Additional Reporting by Joshua Rivera