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:
- TBI-223: Started Phase 1 trial
- TBAJ-876: Completed IND enabling studies, expected to start Phase 1 trial in 2020
- TBAJ-587: Advanced in partnership with Innovative Medicines Initiative (IMI), expected to start clinical-stage testing in 2020
Sustaining the pipeline:
- In collaboration with GlaxoSmithKline, the KasA inhibitor program yielded a compound that has advanced to pre-candidate status.
- Supported by a Center of Excellence in Translational Research (CETR) Grant from the National Institute of Allergy and Infectious Diseases (NIAID), TB Alliance and partners at the University of Illinois at Chicago, Harvard University, Johns Hopkins University and Research Triangle Institute formed a multidisciplinary center to advance translational TB drug research.
- TB Alliance's portfolio of new TB research programs grew by four projects in the past year
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.Learn more
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.