If the trials are successful, the partnership aims to register moxifloxacin for a TB indication and is committed to making it affordable and accessible in developing countries where patients need it most. The trials will take place in Brazil, Canada, South Africa, Spain, Tanzania, Uganda, the United States and Zambia.
The Phase II clinical trial program spans four continents and will enroll close to 2,500 patients with TB. Bayer will donate moxifloxacin for each trial site and will cover the costs of regulatory filings. The TB Alliance will coordinate and help cover the costs of the trials, leveraging substantial support from the U.S. Centers for Disease Control and Prevention (CDC), the Orphan Products Development Center of the U.S. Food & Drug Administration (FDA) and the European and Developing Countries Clinical Trials Partnership (EDCTP).
"We are witnessing an historic moment in global health," said Dr. Maria C. Freire, President and CEO of the TB Alliance. "Today, we stand with Bayer, embarking on a major clinical trial program to see if this excellent antibiotic can shorten TB treatment by 2-3 months, which would significantly improve therapy. 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."
The trials will evaluate whether the substitution of moxifloxacin for one of the standard TB drugs (ethambutol or isoniazid) eliminates TB infection faster than the current standard therapy. * Current TB therapy is based on four drugs discovered forty or more years ago that must be administered for six to eight months, often under the direct observatio