Research & Development

New Therapy Shows Promise of Regimen Development

TB Alliance has long advocated for and advanced the paradigm of developing complete TB drug regimens, as opposed to individual drugs, as the most effective way to reshape TB therapy. Achieving approval from the U.S. Food and Drug Administration (FDA) for a novel regimen for highly drug-resistant forms of TB is the result of this model in action.

In 2019, TB Alliance continued to advance this strategy with additional regimens in development. An increased focus on translational research is designed to secure the portfolio of next-generation clinical-stage drug candidates from which we can form tomorrow’s treatments.

Progress in additional novel regimen trials includes the completion of drug-sensitive (DS) arms of the ongoing SimpliciTB trial. Additionally, the ZeNix trial, evaluating the use of alternative linezolid dosing in the BPaL regimen, completed enrollment at the end of 2019. The study of further new regimens in preclinical models continues to yield promise that universal, short, safe and simple TB therapies are possible.

Developing complete regimens rather than individual drugs dramatically shortens the time to develop a new TB drug regimen

From Compounds to Regimens

Achieving a sustainable pipeline of fully novel, short, safe and effective universal regimens requires the discovery and development of new generations of clinical stage drug candidates. TB Alliance has made significant gains in strengthening its portfolio in 2019, with several key achievements, including:

Sustaining the pipeline:

Tsholofelo Msimango

Improving our Understanding of TB Treatment

TB Alliance makes the findings of its research available by publishing findings on our website, clinicaltrials.gov, at conferences and in peer-reviewed journals on an open-access basis. In 2019, nine peer-reviewed studies were published, including the results of trials of new regimens and learnings regarding the pharmacodynamics, toxicity and dosing of new TB treatments and those under development. A library of our research papers can be found here.

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Advancing New Treatments in Tbilisi, Georgia

The National Center for TB and Lung Diseases (NCTLD) in Tbilisi, Georgia, is a key partner in TB Alliance’s clinical development of new, shorter regimens for TB. Dr. Lali Mikiashvili is the site's lead investigator for the ZeNix clinical trial, which is evaluating a new regimen for highly drug-resistant TB. She has more than 25 years' experience in treating people with TB.

"We are proud to be engaged in this research," says Dr. Mikiashvili. "In partnership with TB Alliance, we are evaluating the potential of new treatments for people suffering from one of the most dangerous diseases in the world."

Georgia has comparatively high rates of drug-resistant TB. In 2018, the WHO reported that approximately 18 percent of all TB cases were resistant to at least one first-line drug, compared to a global average of about 5 percent. By advancing research into new TB drug regimens, the NCTLD is helping to shape the future of TB treatment.

Lali Mikiashvili