Acute Exacerbations of Chronic Bronchitis (AECB) (restricted use)
Acute Bacterial Sinusitis (ABS) (restricted use)
Community Acquired Pneumonia (CAP)(restricted use
Moxifloxacin is currently in clinical trials to evaluate its potential for treatment-shortening for active pulmonary TB. The Bayer -TB Alliance clinical development program to date includes three completed Phase II trials (please see Table) and an ongoing pivotal Phase III trial. Upon completion, these trials will have enrolled more than 3,000 TB patients. These trials have been conducted to date at sites in Africa, Europe, and the Americas, including 10 U.S. States. Two drug regimens are being evaluated, each substituting moxifloxacin for one of the drugs in the standard four drug treatment regimen: the first substitutes moxifloxacin for ethambutol, and the second substitutes moxifloxacin for isoniazid.
The ongoing Phase III trial, called REMoxTB, is a three-arm study in which moxifloxacin is substituted for either ethambutol or isoniazid and is administered for a total of four months. REMoxTB will determine whether these new, four-month regimens are not inferior to standard six-month therapy in terms of failure and relapse, as well as safety. A shorter TB regimen is needed to ease the burden on patients and health systems and to reduce the development of drug resistance.
REMoxTB patient enrollment began in January 2008. A total of 20-30 sites, including sites in Asia (India, China and other Asian countries), Africa and Latin America are being recruited into the study to reach enrollment targets. Assembling this network of sites has spurred an assessment of the readiness and capabilities of TB clinical trial sites worldwide - with a total of 195 sites contacted and 77 sites in 34 countries assessed as of August 2008. REMoxTB protocol-specific assessments have been conducted in addition to these baseline assessments at over 15 sites.
On August 25, 2005, the TB Alliance and Bayer signed an historic agreement: to conduct a global clinical development program, seeking to register moxifloxacin for a TB indication. Should this program prove successful, the agreement includes a joint commitment to ensure the drug's affordability for TB patients in the developing world. Bayer is donating moxifloxacin for each trial and will sponsor regulatory filings. With Bayer, the TB Alliance is managing the overall clinical trial program, ensuring the coordination of information and results towards the goal of registration. University College London and the British Medical Research Council are investing significant intellectual and other resources, specifically in the ongoing Phase III clinical trial discussed below. Financial support for the program comes from the TB Alliance, the CDC, the U.S. Food and Drug Administration Orphan Products Development Center, and the European and Developing Countries Clinical Trials Partnership.