Program areas at TB Alliance
Research and Development - TB Alliance is a not-for-profit product Development partnership (pdp), uniquely positioned to leverage a Global network of public and private partners to most efficiently advance TB Drug Development. A pdp builds partnerships between the public, private, academic, and philanthropic sectors to drive the Development of new products for underserved markets. Pdps retain direct management oversight of their projects, though much of the laboratory and clinical work is done through external research facilities and contractors. We combine the research and Development expertise of our staff with the skills and resources of our partners to harness the most promising science wherever it may exist around the world. This model minimizes costs, including overhead and investments in infrastructure, while optimizing scientific capability to speed new TB Drug Development. Our business model and diverse partnerships allow TB Alliance to leverage additional partner services for every dollar invested in its programs. Simplicitb - simplicitb is evaluating the efficacy, safety, and tolerability of a novel and potentially shorter Drug regimen (bpamz) for patients with drug-sensitive (ds) and drug-resistant (mdr) pulmonary tuberculosis (specifically multidrug-resistant TB and mono-resistance to isoniazid or rifampicin). The bpamz regimen is comprised of four different antimicrobials: bedaquiline (b), pretomanid (pa), moxifloxacin (m) and pyrazinamide (z). The Drug regimen is administered for four months to patients with ds-tb, and for six months to patients with mdr-tb or mono-resistance to rifampicin or isoniazid. Results in the ds-tb arm will be compared to a control group of the standard six-month Drug regimen for ds-tb (hrze). Zenix - the phase 3 zenix clinical trial evaluated the bpal regimen to treat extensively drug-resistant tuberculosis (xdr-tb) and those with pre-xdr-tb and multidrug-resident TB (mdr-tb) whose prior treatment has failed or who have not tolerated their treatment. It sought to optimize linezolid dosing as part of the bpal regimen, evaluating both the linezolid dose and the linezolid duration. The top-line results of zenix were presented at ias 2021, showing that the effectiveness of the bpal regimen could be maintained with reduced dosing of linezolid. These results were accepted and published in the new england journal of medicine in the september 2022 issue. The results of the zenix trial were incorporated into a rapid communication on forthcoming world health organization guidelines for the treatment of drug-resistant TB, issued in may 2022. These guidelines will enable a significantly broader patient population to be treated with bpal-based regimens. Building on evidence first developed from TB Alliance from the nix-tb and zenix clinical trials, as well as the tb-practecal trial run by msf, almost all patients with dr-tb can now be treated in six months with an all-oral regimen. New world health organization guidelines allow for programmatic implementation of treating almost all forms of drug-resistant tuberculosis with either bpalm (a combination of bedaquiline, pretomanid, linezolid, and moxifloxacin) or bpal (bedaquiline, pretomanid, and linezolid). Lift-tb (leveraging innovation for faster treatment of TB) - this access program, launched in 2020, seeks to increase treatment completion rates for drug-resistant TB through adoption and scale up of new regimens, beginning with bpal. It focuses on seven high-burden southeast and central asian countries that shoulder approximately 1 in 5 of the Global TB cases. As of 2022, 50 countries have procured the six-month, all-oral bpal regimen to treat more than 7,000 people with drug-resistant TB. Sutezolid - sutezolid is a promising clinical-stage TB Drug candidate from the oxazolidinone class. TB Alliance has implemented an open Development approach to advance the phase 2 TB Drug candidate, sutezolid, which could be a component of a next-generation TB regimen. TB Alliance has made sutezolid available for study by all researchers who commit to making their results available to the broader TB research community. This novel approach has contributed to three clinical trials that are expected to begin in 2023.
Business Development - TB Alliance negotiates, implements and manages agreements with public and private organizations worldwide and does so by adhering to sound business practices while ensuring the public good. Specifically, TB Alliance negotiates terms that support the Development and access of new affordable anti-tb drugs equitably to those areas most in need while encouraging the private sector to help develop new medicines for TB indications.
PUBLIC AFFAIRS AND POLICY - TB ALLIANCE MANAGES CRITICAL ALLIANCES WITH PUBLIC AND PRIVATE ORGANIZATIONS TO RAISE AWARENESS ABOUT TUBERCULOSIS ("TB") AND ADVOCATE FOR PUBLIC AND PRIVATE INVOLVEMENT IN RESEARCH FOR new anti-TB medicines. It develops landmark studies to support policy developments seeking to accelerate anti-TB drug research and mobilizes networks of researchers and investigators worldwide to focus on the development of these medicines. TB Alliance also engages directly with national TB programs and multilateral institutions to accelerate global adoption of TB Alliance's novel TB treatment regimens. It works in close collaboration with private sector partners and employs novel mechanisms like volume guarantees in keeping with the organization's "AAA mandate" that all new products are adopted, available, and affordable to all in need.