Overcoming the TB pandemic requires new and dramatically improved therapy that will be effective against all forms of TB and can be given to all TB patients
The Universal Regimen
Tuberculosis remains one of the world's leading global health threats. Today's treatments cannot most effectively combat the pandemic because they are too long, complex, and ineffective against drug-resistant TB.
TB Alliance's ultimate vision is to have a transformative impact on the disease by introducing an ultra-short, simple, and affordable TB regimen that works in virtually all people with tuberculosis. This requires a multi-drug regimen comprised entirely of new drugs. Such a regimen would unify the treatment of all current forms of TB under one cure. That paradigm shift would have a major impact on the global epidemic and save millions of lives — and billions of dollars.
To achieve this impact, new regimens must be Adopted, Available, and Affordable.
How We're Getting There
Today, TB, MDR-TB, and XDR-TB are each treated differently — with different drugs, and for different lengths of time. Because there is virtually no resistance to new drugs with novel mechanisms of action, regimens composed entirely of new drugs can treat all types of TB, erasing treatment distinctions. TB Alliance and partners are developing regimens that contain multiple new drugs, including the first completely novel regimen to enter clinical testing, in attempt to transform the TB treatment landscape.
How We're Getting There Faster
Active TB is treated with a combination of drugs. This is necessary to prevent the development of resistance. Traditionally, advances in TB treatment were achieved by replacing a single drug within a combination regimen, or adding a new drug to an existing regimen. This approach may improve efficacy in a clinical trial setting, but does little to address the major challenges of TB treatment, including the long duration, cost, and complexity of treatment.
Using the traditional approach, it could take a quarter of a century to develop a novel regimen. To accelerate the introduction of new regimens, TB Alliance evaluates novel combinations of TB drugs — instead of single drugs — as a single unit. This process begins early in discovery stage research where we identify the most promising combinations of drugs in models. The multi-drug regimens are then evaluated as a unit in later clinical trials. The regimen development approach can greatly reduce the time needed to introduce a fully novel regimen, as well as expands the impact of each regimen.Recently, TB Alliance’s drug candidate, pretomanid, was accepted for review by the US FDA for treatment of XDR-TB and treatment-intolerant or non-responsive MDR-TB, in combination with bedaquiline and linezolid. This combination, known as BPaL, is a novel regimen. The regimen development model greatly accelerated BPaL’s development.
TB Alliance is a member of the Critical Path to TB Drug Regimens, an initiative aiming to accelerate the development of novel regimens. To read more, click here.
Accelerating New Cures for Kids
TB Alliance is working to improve TB cures for all, including children. Historically, children have been neglected both in TB research and control efforts. For new drugs, it could take seven years or longer between the introduction of a new adult medicine and its childhood formulation. With childhood TB such a huge problem, that’s too long to wait. TB Alliance is working to close that gap and accelerate the development and introduction of new TB drugs and regimens for children.