A new collaboration that could radically shorten the time it takes to bring new combination therapies for tuberculosis (TB) to market was launched in Washington, DC last week.

The Critical Path to TB Drug Regimens (CPTR) was created by US-based non-profit the Global Alliance for TB Drug Development along with the Critical Path Institute and the Bill and Melinda Gates Foundation. It will test promising combinations of TB drug candidates early in the development pipeline and look to identify the best new treatment regimens.

Initial partners include scientists from the US Food and Drug Administration (FDA), whose commissioner Margaret Hamburg was at the launch, as well as Johnson & Johnson, Sanofi-Aventis, Pfizer, AstraZeneca, GlaxoSmithKline, Bayer, Otsuka, Novartis, Sequella and Anacor Pharmaceuticals. The initiative also has the support of the World Health Organization.

According to the Global Alliance for TB Drug Development, securing regulatory approval for completely new tuberculosis drug regimens could take as long as 24 years at the moment, as individual candidates are developed and registered separately, then substituted one at a time into existing combination treatments.

The CPTR initiative has the potential to get that time lag down to as little as six years, the Alliance says. It has the commitment of the FDA and regulatory authorities in Europe to help develop and validate “improved, safe and accurate” regulatory pathways for testing and registering combination TB treatments.

“The creative approach mirrors FDA’s own investments in innovative regulatory science that ensures the best new medical technologies – including combination therapies – reach patients as soon as possible,” Hamburg commented.

TB kills some 1.8 million people a year, mainly in developing countries. The standard four-drug course of treatment means taking tablets for six months or longer, which has contributed to the rise of drug resistance. In 2007 there were more than 500,000 cases of drug-resistant TB worldwide.

Currently there are nine promising TB compounds from at least six antibiotic classes in clinical trials or late preclinical development, offering “an unprecedented opportunity for collaboration”, the Global Alliance noted. New TB drug combinations could cut treatment times and provide efficacy against both drug-susceptible and drug-resistant TB strains.

“No single company or institution can do it alone,” said Dr Paul Stoffels, global head, pharmaceuticals research and development at Johnson & Johnson. “Industry has to continue to focus on innovation and accelerate the discovery and development of new compounds with new mechanisms of action, and at the same time work in collaboration with regulators, non-profit organisations and other partners to accelerate testing of new combination regimens as early as possible in development.”

The CPTR will be coordinated by the Critical Path Institute, the independent, non-profit organisation set up in the US to foster innovative collaborations in regulatory science that can optimise the efficiency and safety of medical product development.

The collaboration will welcome participation from any company with a promising TB drug candidate in development, as well as other companies and organisations with the technical expertise or resources to help develop new TB regimens.

To facilitate clinical research involving combination TB therapies, the CPTR partners are also exploring creative funding mechanisms and potential trial site support for Phase IIB and Phase III clinical trials.