The Global Alliance for TB Drug Development (TB Alliance) and Bayer Healthcare AG entered into a partnership to coordinate a global clinical trial program to study the potential of an existing antibiotic, moxifloxacin, to shorten the standard 6-month treatment of tuberculosis (TB).
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, according to a Bayer release.
The phase II clinical trial program spans four continents and will enrol 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 US Centres for Disease Control and Prevention (CDC), the Orphan Products Development Centre of the US FDA and the European and Developing Countries Clinical Trials Partnership (EDCTP).
Dr. Maria C. Freire, President and CEO of the TB Alliance said, "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."
Mycobacterium tuberculosis infects one-third of the world's population, resulting in nine million new cases of active TB and two million deaths each year. Public health experts note that a shorter TB regimen would help ease the economic burden, estimated at $16 billion a year, and enable healthcare workers to treat more patients.