2023 was really such a gratifying year because we now are seeing the beginning of an explosion of being able to actually see thousands and thousands of patients benefit from new treatments. And, when all is said and done, that’s the goal.”
Mel Spigelman,
President and Chief Executive Officer
TB is one of the world’s oldest and deadliest diseases – infecting 10 million people worldwide and killing
1.3 million
people in 2022 alone.
TB Alliance is dedicated to improving treatment for TB, and in recent years, the team has worked diligently to also ensure that new treatments reach everyone who needs them. I’m proud to be part of an organization that is transforming the way we think about what’s possible for TB treatment and addressing challenges head on.”
David Norton,
New Chair of the TB Alliance Board of Directors
Since the approval of pretomanid and the BPaL regimen, TB Alliance and partners have continuously worked to optimize the regimen to provide the best possible treatment experience for the largest number of people.
Our vision for TB research and development prioritizes the pursuit of universal regimens—meaning that all people with all forms of TB can be treated with the same therapy.
In 2023, we worked to significantly expand the number of people able to access improved DR-TB therapies. To date, pretomanid has been procured by 70+ countries in quantities to reach more than 40,000 people—a quarter of the number of people treated for DR-TB each year.
TB community experienced a significant resurgence driven by in-person gatherings and building momentum through advocacy. Together, with partners, stakeholders, and advocates, we worked to shine a spotlight on TB on a global stage.
In 2023 we were funded by 14 organizations and partners from 9 countries.
Toward Improved TB Treatment for All
Since the approval of pretomanid and the BPaL regimen, TB Alliance and partners have worked continuously to optimize the regimen to provide the best possible treatment experience and outcomes for the largest number of people. The evolution of BPaL has included a reduction in daily linezolid dose and the recommendation by the WHO to use BPaL with or without moxifloxacin in nearly all people with drug-resistant TB. In 2023, major steps were taken to further grow the populations who can benefit from pretomanid. These advances include the launch of a Pan-Phase 2 clinical trial (NC-009), testing pretomanid and linezolid in combination with a new compound, TBAJ-876, in people with drug-sensitive TB, as well as the first trial of pretomanid in participants under the age of 14. TB Alliance’s vision for TB research and development (R&D) prioritizes the pursuit of universal regimens—meaning that virtually all people with all forms of active TB can be treated with the same therapy. These new trials are significant steps toward optimizing pretomanid-based regimens as universal therapies.
Testing a “Universal Regimen”
Late in 2023, TB Alliance launched NC-009, a new Pan-Phase 2 clinical trial incorporating elements of Phase 2a, b and c trials. NC-009 aims to evaluate the safety and efficacy of a combination of a new experimental compound, TBAJ-876, with pretomanid and linezolid. Results from preclinical and Phase 1 studies showed that TBAJ-876, eliminated TB bacteria faster and had a potentially safer profile than bedaquiline (a drug of the same class). This regimen has the potential to shorten and improve treatment for both drug-sensitive and drug-resistant TB and may serve as a true universal regimen. If successful, such a breakthrough would allow virtually all people with TB to be treated with the same regimen, dramatically simplifying TB treatment.
Landmark Agreement to Advance Development of New TB Treatment
In early 2023, TB Alliance and Qurient Therapeutics, a biotechnology company based in South Korea, entered into a license agreement to develop and commercialize telacebec (Q203), a first-in-class cytochrome bc1 inhibitor for the treatment of TB and other non-tuberculosis mycobacterium (NTM) infections. Q203 has shown potential against drug-resistant forms of TB, as well as against Buruli ulcer, a chronic, necrotizing disease that affects a person’s skin and sometimes bone, and leprosy, a debilitating, disfiguring, and stigmatizing disease.
New Research to BENEFIT Kids
The BENEFIT Kids program, funded by UNITAID and led by Stellenbosch University in collaboration with TB Alliance, aims to address the lack of high-quality evidence on access to medicines to prevent and treat drug-resistant TB in children. Throughout 2023, BENEFIT Kids published a series of research papers in the International Journal of Tuberculosis and Lung Disease (IJTLD) highlighting the importance of child-friendly formulations for DR-TB, including community perspectives on child-friendly formulations and a novel home-based method for preparing suspensions. This at-home method was also demonstrated by Dr. Raj Taneja, Vice President, Pharmaceutical Product Development at TB Alliance, at the 2023 Union Conference in Paris.
SPOTLIGHT: Advancing Child-Friendly Medicines
TB Alliance has enrolled its first participants in a Phase 1 pediatric clinical trial evaluating the pharmacokinetics (PK), safety, tolerability, and acceptability of the TB medicine, pretomanid – an important step in making the BPaL/M regimens, recommended by the World Health Organization (WHO) for treating adults with drug-resistant TB, appropriate and available for children.
This trial is an important step in bringing life-saving technologies to our littlest patients.
— Pauline Howell, co-principal investigator, Sizwe Tropical Disease Hospital, Johannesburg
Speeding New DR-TB Treatments to Those in Need and Creating Tangible Impact
In 2023, TB Alliance worked to significantly expand the number of people able to access improved DR-TB therapies. To date, pretomanid has been procured by 70+ countries in quantities to reach more 40,000 people—a quarter of the number of people treated for DR-TB each year. Success in rapid expansion of access has been due to a variety of initiatives to generate evidence of BPaL’s real-world impact, assist in treatment policy development, ensure product supply at low prices, and support local technical support and advocacy for the rapid adoption of new TB treatment technologies. We quantified and published potential global savings from implementation of BPaL/M which could be up to $740 million annually.
LIFT-TB Countries Take the Lead in Updating Treatment Guidelines
Countries included in TB Alliance’s LIFT-TB initiative have been at the forefront of accelerating the adoption and scale up of pretomanid and BPaL. Driven by the performance of the regimen in operational research and the inclusion of pretomanid in WHO DR-TB treatment guidelines, five of the seven LIFT-TB countries (Kyrgyzstan, Ukraine, Uzbekistan, Indonesia, and Myanmar) have updated local treatment guidelines to endorse use of pretomanid and BPaL for nearly all DR-TB cases. All LIFT-TB countries are working to scale up the use of pretomanid and BPaL as the national standard of care. Other major countries where TB Alliance initiatives supported rapid adoption and roll out during the year were South Africa and Pakistan.
Enhancing Access to All-Oral, Six-Month DR-TB therapy
The addition of pretomanid to the Essential Medicines List (EML) of the World Health Organization (WHO) is a critical step towards speeding universal access to the BPaL/M regimens for people suffering from drug-resistant (DR) TB.
With this listing, the novel six-month regimens received a further endorsement on the path to providing improved outcomes for all eligible patients, replacing older, toxic, and often ineffective combinations that oftentimes required 18 months or longer treatment.
— Dr. Mel Spigelman, President and CEO, TB Alliance
Fast Tracking New Cures with Global Grassroots Partners
In support of the WHO’s Call to Action to accelerate access to shorter DR-TB cures for all, in 2023, TB Alliance and partners launched Fast Track the Cure, a movement to unite communities around the world to make their voices heard to world leaders that six-month DR-TB cures must be widely adopted and available to all who need them. Partners from countries around the world worked on the ground to advocate and hold events to accelerate local and regional adoption and scale-up of six-month, all-oral DR-TB therapies, like BPaL/M. Partners also launched coordinated online advocacy tools and campaigns around the #6MonthsMax hashtag, including a global petition and inclusive social media toolkit.
The Year in Photos
In 2023 we saw a year of progress in getting treatments into the hands of people who need them. By the end of the year, 40,000 people had accessed short, six-month, all-oral treatment for DR-TB. These photos show how advancing a pipeline for improved TB medicines can have a direct impact saving and improving the lives of people around the world.
Browse the entire gallery on Pixieset
SPOTLIGHT: “Because of this New, Novel Regimen, My Body Felt Stronger” – Joi’s #6MonthsMax Story
Joi was diagnosed with TB in 2022. He was first given therapy for drug-sensitive TB, only to find—months later—that his TB was drug-resistant. Joi was then switched first to a nine-month regimen, then again to an 18-month regimen. But Joi didn’t respond well to either course. He suffered from many side effects of the treatment, including vomiting, dizziness, loss of appetite, significant weight loss, and skin rashes. Joi was then able to access BPaL as part of the operational research program associated with the LIFT-TB initiative in his country, The Philippines. Almost immediately, Joi’s condition improved dramatically. On BPaL, Joi was cured of his DR-TB with minimal side effects. In reflecting on his experience with the regimen, Joi noted, “This new novel regimen is good for me because it is lesser pill burden, lesser duration, and less side effects.” Today, Joi is healthy and has taken to advocate for widespread access to new, short, and effective DR-TB cures for all.
Revitalizing the TB Community
In 2023, the TB community experienced a significant resurgence driven by in-person gatherings and building momentum through advocacy. Throughout the year, TB Alliance joined and hosted many in-person events—a growing trend in a post-COVID world—and worked with fellow non-profit organizations dedicated to TB to foster collaboration and reignite enthusiasm within the TB community and more broadly. Together, we worked to shine a spotlight on TB on a global stage at the United Nations and galvanize support for enhanced research, funding, and policy interventions. As a result, 2023 stands as a pivotal year where collective action and determination infused new energy into the TB field, offering hope and renewed focus in the pursuit of a TB-free world.
TB on a Global Stage at the UN
The 2023 United Nations High-Level Meeting on Tuberculosis (UNHLM) saw world leaders come together to commit to increased political will and funding to combat the TB pandemic in the form of a newly adopted Political Declaration. TB Alliance wholeheartedly supports the commitments made at the UNHLM on TB to fight this age-old disease and we worked with partners leading up to and during the week of the UN General Assembly to help draw global attention to this global disease. Along with our partners at FIND and IAVI, we co-hosted a side-event to address the challenges faced in combatting this deadly disease, revisiting previous commitments and progress, and renewing our focus to achieve TB elimination.
Joining Partners to Advance New TB Tools
In November 2023, ahead of the Union World Conference on Lung Health in Paris, TB Alliance held its Stakeholders Association Annual Meeting to highlight recent advances in TB drug development and delivery efforts. Key topics of the event included the announcement of a newly launched Pan-Phase 2 clinical trial, NC-009, testing a potential “universal TB regimen,” an update on the global rollout and uptake of pretomanid and BPaL regimen, and a panel discussion featuring health officials of TB-endemic countries relaying their experiences and insights regarding the adoption, use, and future plans for pretomanid and the BPaL regimen. This meeting was part of a full-day summit hosted by IAVI, FIND, and TB Alliance, as well as the TB New Tools Working Groups, as an opportunity to gather together ahead of the Union Conference to share updates in TB research related to vaccines, diagnostics, and treatments.
Engaging Communities
In March 2023, we hosted the first in-person Community Engagement Forum since before the COVID-19 pandemic. Our colleagues and partners joined us in Johannesburg for a two-day seminar that discussed a variety of topics, including Good Participatory Practices, Stakeholder Mapping, Youth Engagement, as well as an in-depth discussion and training on results from TB Alliance’s research, including SimpliciTB and BPaMZ/SEM. This was a true hybrid forum, as many of our Community Engagement partners were able to join us in Johannesburg, but the event was also streamed for presenters and participants who joined virtually.
Our Financials
The tremendous progress in advancing new TB cures and ensuring they reach those in need was achieved despite continued funding shortfalls for this critical, lifesaving work. In September 2023, the UN held its second HLM on TB and set a goal for annual investments in global TB efforts at US$27 billion by 2027, including US$5 billion annually for research. The goals are multiple times current funding levels, despite a commitment to close the TB funding gap made at the 2018 HLM. With adequate investment and political will, ending TB is possible but our global community must work together to ensure we remain accountable to our commitments if we are to achieve a TB-free world.
SPOTLIGHT: TB Survivor and Founder of TBPeople Philippines: Louie Zepeda-Teng
“In late 2006, when Zepeda-Teng was a 24-year-old architecture graduate working in Manila, she contracted tuberculosis (TB) – an ancient killer still common across the Philippines. She deteriorated quickly; bar hopping with friends was traded for long nights in hospital as the infection escalated. The bacteria had escaped her lungs and began attacking her brain as meningitis set in.”