Bayer Healthcare AG has signed an agreement with the Global Alliance for TB Drug Development to study whether the quinolone antibiotic, moxifloxacin, can reduce treatment times for tuberculosis.
Current therapy for TB (isoniazid, rifampicin, pyrazinamide and ethambutol) requires six to eight months of treatment, but moxifloxacin could reduce this by two to three months. Already studies in mice have shown that the drug can reduce treatment times by two months, the partners say.
Some 2,500 patients will be recruited for the four Phase II studies, which will span countries in four continents Brazil, Canada, South Africa, Spain, Tanzania, Uganda, the US and Zambia.
Bayer will donate the drug for the trials and will cover the costs of any regulatory filings, which could take place in 2009-10. The TB Alliance will manage the trial programme, ensuring co-ordination of information and results.
The studies will substitute moxifloxacin for one of the standard TB drugs (ethambutol or isoniazid) and evaluate whether it can eliminate TB infection faster than current therapy. The primary endpoint will be the presence of culture-negative sputum after two months of therapy.
The trials will not include any patients under 18 years of age, as moxifloxacin has yet to be formulated in a palatable syrup, the TB Alliance told Scrip. "It is extremely difficult to mask the [very bitter] taste."
Both partners promise to make moxifloxacin available at an "affordable" price in low and lower middle-income countries.
Moxifloxacin is also safe to use with antiretrovirals as it is not metabolised by cytochrome P450 enzymes. This is a bonus as patients in developing countries are often co-infected with the HIV/AIDS and TB.