TB Alliance's high-dose regimen meets in Phase IIb

The not-for-profit Global Alliance for TB Drug Development said once-daily 200 mg PA-824 in combination with moxifloxacin and pyrazinamide -- what the alliance calls the PaMZ TB regimen -- met the primary endpoint vs. once-daily Rifafour rifampicin/isoniazid/ethambutol/pyrazinamide in the Phase IIb NC-002 trial to treat tuberculosis (TB) infection. The dose of PA-824 in combination with moxifloxacin and pyrazinamide led to a greater average daily reduction in colony forming units (CFUs) counts over eight weeks vs. once-daily Rifafour from Sanofi (Euronext:SAN; NYSE:SNY) (p<0.05). A 100 mg dose of PA-824 in combination with moxifloxacin and pyrazinamide missed the primary endpoint vs. Rifafour.

The open-label, South African and Tanzanian trial enrolled 181 patients with drug-sensitive TB infection. In the trial, 20% of patients were also co-infected with HIV. The alliance said there was no interference or side effects between the PaMZ regimen and the antiretroviral therapies being taken by co-infected patients. Data were presented at the International AIDS Conference in Melbourne. ...