An alliance of tuberculosis researchers is partnering with Bayer AG of Germany to conduct the first major clinical trial program of a potential tuberculosis drug in more than 40 years.
TB is one of the world's most fatal diseases, killing two million people a year world-wide, mostly in poor areas, according to the Global Alliance for TB Drug Development. The most widely used treatment, however, hasn't been updated since the 1960s. The pills must be taken for six months to clear the body of the bacteria causing the respiratory infection, and many patients stop taking the medicine ahead of schedule, which can exacerbate their illness.
The new clinical trial program is designed to test whether a new Bayer drug, an antibiotic, can cut treatment time nearly in half, which would raise patient compliance and improve care. If the drug proves effective, Bayer said it will supply it, at cost, to TB patients in the developing world.
"If successful, a new, shorter regimen could be available in the next five years, making the difference between life and death for millions of TB patients," said Maria Freire, president and chief executive of the Global Alliance for TB Drug Development, New York, which is coordinating the clinical trial program.
The antibiotic, moxifloxacin, is already on the market for the treatment of other respiratory infections. In recent years doctors have used it unofficially on TB patients and found it effective.
The program will include four separate trials on 2,500 patients in eight countries in Africa, North and South America, and Europe. Bayer is donating the drugs; the trial costs will be covered by the U.S. Centers for Disease Control and Prevention; the European and Developing Countries Clinical Trials Partnership; and the Global Alliance for TB Drug Development, which is largely funded by the Bill & Melinda Gates Foundation.
Some of these groups also are searching for new TB vaccines and diagnostic tools to replace the decades-old products used today.