TB Alliance: Putting science to work for a faster TB cure

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Developing Regimens

The TB Alliance and its partners are leading the clinical development of a new generation of markedly improved TB cures. These drugs are the building blocks of novel TB regimens, which will speed the introduction and unleash the transformative impact of new, faster, and better TB drugs for drug-sensitive and drug-resistant TB.

The TB Alliance isn't just developing new TB drugs, but leading a revolution in the way that TB drugs are developed to speed the development and maximize the impact our products will have on the TB pandemic. The regimens in development include potential improved solutions for TB, MDR-TB, and XDR-TB, for adults and children.

CHANGING THE WAY
WE
DEVELOP A NEW TB
DRUG REGIMEN

Since the 1950s, researchers have known that TB treatment must be delivered in multi-drug regimens to prevent the development of drug resistance. Traditionally, improvements in TB therapy were achieved by replacing a single drug within a regimen, or adding a new drug to an existing regimen. With growing levels of drug-resistance, unacceptably long and complex treatments, and millions dying each year, we need more than incremental gains; we need game changing innovation.

Achieving maximum impact on the epidemic requires a short, simple, and affordable regimen comprised of all news drugs, circumventing the challenges posted by resistance to some of the antibiotics available today. A universal regimen could erase the distinctions between various strains of TB and be effective in virtually all people with active TB. A product with such broad utility would significantly improve TB control efforts globally. TB Alliance's regimen development strategy pursues this larger goal through a series of clinical trials.

Novel Regimens in Development

The PaMZ regimen, consisting of one novel drug candidate pretomanid, (formerly PA-824), moxifloxacin, and pyrazinamide, is the most advanced novel regimen currently in development. It shows promise to improve treatment for those with drug-sensitive TB and those with TB/HIV co-infection.

Treatment for men, women, and children

In addition to the development of new TB drug regimens, TB Alliance is also committed to improving the treatment of TB in children — an area traditionally neglected. Currently, working with partners, we are developing a child-friendly formulation of today's first-line TB therapy. We are also committed to accelerating the development of pediatric formulations of our new regimens in development.

It also shows the potential to markedly improve treatment of many patients with multi-drug resistant tuberculosis (MDR-TB) by being dramatically shorter, simpler, safer, and more affordable than current standard therapy. PaMZ is currently in its final stage of testing — a global Phase 3 clinical trial called STAND.

The BPaZ regimen takes the next step toward unifying treatment. It is comprised of two novel drugs, bedaquiline and pretomanid, in addition to pyrazinamide. The regimen shows potential to treat drug-sensitive tuberculosis and some forms of drug-resistant TB in as little as three months. BPaZ is currently undergoing a two-month Phase 2b clinical trial, called NC-005, which began in 2014.

The regimen being tested in Nix-TB (New Investigational Drugs for XDR-TB) has the potential to treat all forms of active TB to enter clinical trials and could be a "universal" regimen. The Nix-TB trial will start by testing a regimen consisting of bedaquiline, pretomanid, and linezolid in XDR-TB patients, offering hope to patient population that currently has virtually no other options. If successful among XDR-TB patients, the trial could expand to include people with other types of TB. The trial has a flexible base, upon which the regimen could be improved if new compounds became available.

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A New Paradigm in TB Drug Development