World TB Day 2025: Preparing for clinical trials
Posted on: 24 March 2025 by Rebecca Derrick in LONGEVITY Blog
24 March is World Tuberculosis Day, so the Centre of Excellence for Long-acting Therapeutics (CELT) want to update you where our ground-breaking long-acting tuberculosis (TB) prevention medication is up to.
What is World TB Day?
The World Health Organization (WHO) designated World TB Day to raise awareness of its “devastating health, social and economic consequences”. The date was selected as it was 24 March 1882 that Dr Robert Koch announced he’d identified the bacterium that causes TB. This information was key in the journey towards effective TB diagnosis and cure.
Why is TB one of CELT’s focuses?
We use this day to amplify the urgent need to end TB, the 2025 theme from WHO is ‘Yes! We can end TB: Commit, invest, deliver’. Directed by Professor Andrew Owen and Professor Steve Rannard, CELT oversees the LONGEVITY project, funded by global health agency Unitaid. LONGEVITY is an international consortium of mixed disciplines and expertise, all working towards creating long-acting preventative treatments for tuberculosis. Equitable access in low- and middle- income countries (LMICs) is at the heart of all medicine being developed through LONGEVITY, for TB as well as for malaria and hepatitis C virus. These are the countries where these diseases have the most devastating impact.
We’re working towards long-acting preventative options for TB, because we can see the devastating impact it is having globally. It is now more important than ever to maintain our efforts to be part of global eradication efforts. At the end of 2024 Berida and Lindsley published a paper in the Journal of Medicinal Chemistry stating TB is again the biggest cause of death from a single infection disease. The piece also highlights TB’s reputation as the deadliest infectious disease in recorded history.
With this knowledge, the WHO state
Stronger commitment is crucial, especially as declining international funding for TB in the current geopolitical climate threatens the achievement of global targets to end TB by 2030.
With 1.25 million TB deaths in 2023, it is a global issue. However, 86% of TB cases in 2023 were in the WHO South-East Asia Region (45%), African Region (24%) and Western Pacific Region (17%). Over two thirds of the world’s total cases were in Bangladesh, China, Democratic Republic of Congo, India, Indonesia, Nigeria, Pakistan and the Philippines. There is a clear division in global TB incidence, with LMICs experiencing the worst of it.
The 2025 funding cuts are widely anticipated to have a devastating impact on TB programmes, particularly in LMICs that rely heavily on international aid, given the United States has been the largest bilateral donor. Eighteen of the highest burden countries depended on 89% of the United States funding for TB care.
In a recent WHO news piece Dr Tereza Kasaevain, Director of WHO’s Global Programme on TB and Lung Health, is quoted as saying
Without immediate action, hard-won progress in the fight against TB is at risk. Our collective response must be swift, strategic and fully resourced to protect the most vulnerable and maintain momentum toward ending TB.
Where is LONGEVITY’s long-acting TB preventive work up to?
LONGEVITY’s TB work is at a really exciting part of its journey. We are working on creating long-acting versions of two existing TB prevention drugs, rifapentine and isoniazid.
As both of these TB antibiotics are already on the market, we know they work and that they are safe to use. The process to make isoniazid suitable as a long-acting product is longer than that for rifapentine as it includes multiple additional stages which we have completed.
Rifapentine
The long-acting version of rifapentine has shown great promise in preclinical models and we have contracted a contract development and manufacturing organisation to manufacture Good Manufacturing Practice (GMP) batches. The GMP batches are first evaluated in toxicology studies. The outcome will provide the data we need to progress an application for regulatory approval for taking it into a clinical trial. Toxicology studies provide support that a medicine will be safe in humans.
Our contract development and manufacturing organisation have successfully reproduced the method for making our long-acting rifapentine, scaled it, and sterilised it. It is important that new medicines are stable during storage, known as the shelf-life, and that the period of stability is understood to allow a use-by-date to be applied. For distribution in LMICs it is critical to avoid the need for a cold chain, so this is a key target for our development work.
Isoniazid
The journey for our long-acting isoniazid prodrug mirrors that of rifapentine, and we are currently working on achieving preclinical proof of concept. We know we can make it, that it can be made in large quantities, and we’ve already demonstrated that the prodrug synthesis is feasible. In preparation, we have already found a contract development and manufacturing organisation and are in the process of translating the methodology before moving on to the next steps.
Why is LONGEVITY’s long-acting TB research and work important for patients?
Despite all the statistics at the start of this blog and the knowledge that TB is currently the biggest single infectious disease killer, TB is both preventable and curable. For many reasons, TB is not being prevented or cured at sufficient speed in LMICs, and we hope that these new tools will help to turn the tide.
Existing medications for TB prevention and treatment are either not accessible to LMIC patients or are not suitable for their lifestyles. This is why the LONGEVITY consortium is focused on availability of our long-acting injectable TB options in LMICs. The work discussed above is just a part of the LONGEVITY consortium’s hard work for long-acting TB prevention therapies. Our public engagement teams are also working hard with policy makers, providers and patients to understand interest and attitudes towards long-acting medicine in regions where they are most needed.
Prof Andrew Owen, co-Director of CELT and principal investigator for LONGEVITY said
The greatest reward for all of us working so hard to implement long-acting tuberculosis preventative therapy would be to see them available to the physicians and patients in LMICs that so desperately need these potentially transformative tools.
Yes! We can end TB: we are committed, we are investing, we will deliver.
#WorldTBDay #WorldTuberculosisDay
The LONGEVITY project aims to simplify TB, malaria and hepatitis C virus treatment and preventative treatment to reduce the drug burden and the number of patients requiring complex therapies for active disease.
Find out more about the LONGEVITY project
The LONGEVITY Project is funded by global health agency Unitaid
The project also involves critical partners and collaborators in the Clinton Health Access Initiative, Johns Hopkins University, Medicines Patent Pool, Tandem Nano Ltd., Treatment Action Group and the University of Nebraska Medical Center
