TB cocktail developers hope promising data point to regulatory shortcut

A new cocktail therapy that matches an experimental therapy with a long-approved antibiotic and TB treatment effectively wiped out signs of a drug-resistant form of tuberculosis in a mid-stage trial. And the developers are hoping that new guidelines at the FDA on urgently needed remedies could pave the way to a quick approval.

Investigators tested PA-824, moxifloxacin and pyrazinamide and found that the combo not only offers a better weapon to use against drug-resistant TB, it may also provide a much simpler solution for patients who are currently faced with injections and a long regimen of pills every day. Another plus: The cocktail doesn't seem to spur any adverse reactions among patients taking HIV drugs.

The TB Alliance sponsored the Phase IIa study and a IIb follow-up trial is being planned. More positive signs would lead to a late-stage trial and possibly an approval in relatively short order.

"After a new drug reaches the market, the traditional route is to work from the standard of care and substitute one drug for another," Melvin Spigelman, president of the TB Alliance, tells Nature. "But if you do it in an incremental way, that will give you incrementally better results. Our goal is to shorten the path to getting a new, cohesive regimen out there in one fell swoop."

- here's the Nature story
- get the report from Business Day