4 December 2025
Tuberculosis is consistently in the top three communicable pathogens globally. In 2021, MPP signed a licence agreement with Tandem Nano Ltd., the University of Liverpool start-up focused on the development of its proprietary long-acting nanosystems [LG1] platform technology. There is much excitement in the tuberculosis treatment community about the potential of this long-acting medicine, with several members of MPP’s Community Advisory Panel (CAP) acting as a bridge between the scientific innovators and the community at large.
The non-exclusive, worldwide licence covers the patents and expertise of promising long-acting injectable technologies (LAIs) that could be used across disease areas with high prevalence including tuberculosis (TB) and hepatitis C (HCV). The research teams are designing medicines to be delivered through a single injection to achieve the desired effect on pathogens over prolonged periods, mitigating the need for daily oral pills, among many other advantages at the individual and community level.
MPP recently spoke to the three leading members of the Longevity team, which is developing the long-acting injectables for latent tuberculosis infection, to discuss progress.
Andrew Owen (AO) is professor of pharmacology and co-director for Centre of Excellence in Long Acting Therapeutics (CELT) at the University of Liverpool. He is also the principal investigator for Project LONGEVITY, funded by Unitaid.
Steve Rannard (SR) is professor of chemistry at the University of Liverpool and co-director of CELT. He’s also an adviser to Tandem Nano and director of the UK National Hub for Advanced Long-Acting Therapeutics (HALo) and a co-investigator on Project LONGEVITY.
Antony Odell is the CEO of Tandem Nano. Its principal role is to assist licensing efforts, and developing and undertaking freedom to operate (FTO) work on patents.
MPP
What is latent TB?
AO
Active TB disease is what people think about more frequently when they consider the disease. But persons with latent TB are often not exhibiting any symptoms and are otherwise healthy. The bacteria are dormant in the body and may become active, potentially causing TB, years or even decades after the initial infection.
Andrew Owen
Why is latent TB specifically important to treat?
Treating latent TB prevents the progression to active TB. Without TB preventative treatment (TPT), around 5-10 per cent of people with latent TB will eventually develop active TB, typically when their immune defences drop due to age or illness. Most new TB cases in countries with low TB rates stem from untreated latent TB infections transitioning to the active disease.
So by treating latent TB, the overall incidence of TB in communities declines. Crucially, treatment for latent TB is generally shorter and less complex than treatment for active TB.
Could you please describe the current oral treatment options for latent TB?
The most common oral treatments for latent TB use either isoniazid, rifampicin, or a combination of isoniazid and rifapentine, with total pill counts and treatment durations varying by regimen.
The pill count depends on the specific dose and patient weight, but commonly ranges from 1-8 pills per dose, with total treatment periods ranging from three months (12 doses) to four months (120 doses) for current preferred regimens.
Could you explain why long-acting medicines for TB are so important? What difference will they make?
TB remains a major global health threat, with over 10 million active cases globally, and 1 million death every year. Some estimates put the prevalence of latent TB at around one-third of the global population. Most people are unaware that they are carrying TB and they don’t exhibit symptoms. Approximately one in ten of those with latent TB infection will develop the active disease. We’re specifically focused on latent TB infection. Treatment options for active and latent TB are different and there’s a whole set of complications with active TB.
SR
If you’re diagnosed with latent TB, the actual course of medication is extremely long. It’s actually called a sterilisation course, and it aims to remove the infection. But patients are not very motivated to do that because they don’t have symptoms. They’re not ill and they’ve got months of medication which they’re taking for what appears to be no benefit.
Steve Rannard
Essentially, humans are really bad at remembering to take medicine. The beauty of a long-acting regimen is that once the clinician administers the dose, the person is free to carry on with their life without needing to remember to take their meds every day. They are kept healthy without a daily reminder.
Why has there still been no approval for a long-acting regimen to manage TB?
AO Long-acting treatment and prevention is now very successful with HIV and that’s focused a lot of minds around the potential benefits of long-acting delivery in infectious diseases more generally.
Secondly, a lot of the TB drugs are extremely old. These drugs were developed as oral products because oral pills have always been seen as the simplest modality for patients. But over the last 20 years, there’s been a real transformational acceleration of technologies for drug delivery, specifically particle processing technologies. That’s opened up new opportunities for formulating drugs.
Antimicrobial drugs are still being used, very old drugs, but resistance is becoming more of a problem. It hasn’t reached a level where there’s a commercial incentive for companies, but there are a number of initiatives underway. Several countries are trying to create incentives for big companies to develop new antimicrobial agents, and global health agencies are heavily investing and calling for a stronger collective commitment to end TB.
There has been massive investment in TB drugs especially from Unitaid and The Global Fund, with the latter providing 73 per cent of all international financing for TB – equivalent to US$10.5 billion in programmes to prevent and treat TB, and an additional US$8.6 billion in TB/HIV programs as of June 2025.[1]
Recently, there has been a lot of clinical trial activity directed towards treatment shortening regimens for tuberculosis. The BRIEFTBshowed that one month of rifapentine with isoniazid was as effective as nine months of isoniazid alone. That was an encouraging signal for the development of long-acting regimens for latent TB, as achieving a month of coverage is readily achievable for a long-acting injectable, whereas nine months would be much more challenging.
Antony Odell It’s going to be generic manufacturers we partner with and even the generics are going to need a financial incentive to do what they’re doing. Generic manufacturers are going to look at supplying LMICs, but they’re going to look at other opportunities as well. MPP’s role is very critical as it’s going to make it an attractive package to those generic manufacturers.
Antony Odell
SR This is exactly the value of a partnership with MPP and having them embedded within Project LONGEVITY. MPP understands working with generic companies and it’s a trodden path for them. The skillset and network that MPP has are critical to what we’re doing.
Could long-acting potentially ease the burden of treatment and prevention simply because it has a shortened treatment regimen?
In some places, carrying pills for TB has been identified as stigmatizing. A more discrete approach, such as with an injection that could be administered just once at the start of the treatment, removes the potential stigma because the person isn’t carrying anything around which is a marker of their disease.
Ordinarily, you might give a course of pills for the person to take away, but attending all follow-up appointments might be challenging. However, if a patient has been treated effectively through a long-acting medicine at that first clinic visit where they’ve been diagnosed, then that’s less of an issue, especially when the person is living a very long way from the clinic.
Finally, receiving an injection that covers weeks of exposure to the medicine ensures a higher efficacy and obviates the emergence of resistance, because it is not dependent on adherence to the medicine. In other words, the person does not need to remember to take their meds every single day for the whole duration of treatment.
Could health spending be reduced or avoided by a long-acting regime?
AO There’s the cost of treatment and then there’s the wider healthcare costs. In terms of the drug costs, long-acting injectables almost always require less drug overall. When the dose is normalised across the entire dosing interval, the active pharmaceutical ingredient costs are proportionally lower to treat a patient.
Then, if the persons are less sick, and if there’s less transmission of TB in the community, and people are healthier, then there’s obviously a bigger cost saving on healthcare systems. This requires detailed cost effectiveness analyses, but we would anticipate that there would be a considerable overall healthcare cost saving.
Also, the associated packaging ends up in the environment. When unused medicines are disposed of, pharmacologically active molecules may be placed into landfill sites, and ultimately released into the environment. By directly administering an injection to the person, this can all be avoided.
AO We’re embarking on a piece of work with Unitaid to better understand the climate and sustainability implications of long-acting product development. Later in the year we’re planning on disseminating a report on that, along with our assessment.
In terms of the development itself, we’ve screened a library of formulations. We’ve done preclinical assessments hand in glove with that formulation screening and we’ve selected formulations that perform extremely well preclinically.
We’re working with the clinical teams in the consortium to develop clinical trial protocols. We’re also engaging with regulatory agencies to ensure that our Good Laboratory Practice toxicology protocols are fit for purpose and that the clinical trial protocol will give us the information we’ll need for regulatory decision making downstream. We’re very close now to going into phase one studies with a long-acting medicine for TPT.
Part of the role that Unitaid tasked us with was to establish the intellectual property that’s generated as part of the programme and ensuring that there are no impediments to it being used by generic manufacturers. So our role has been to conduct extensive FTO searches in the major markets where that might occur. We’ve focused on Europe and the US.
For rifapentine, searches have just begun and we’ll be reporting back before the end of the year. But we’ve conducted FTOs for the other parts of the programme, and they have come back clear of any obvious restrictions.
AO We’ve also undertaken considerable engagement with communities. We’ve engaged with patients, and clinicians in LMICs through surveys to understand acceptability for long-acting medicines and to identify potential barriers and drivers.
Those surveys have now been published and have demonstrated a high acceptability for long-acting modalities for LTBI.[3] This activity has been led by collaborators at the University of Nebraska Medical Center and Treatment Action Group (TAG). TAG have also created a long-acting technology community advisory board (LATCAB).
From the FDA, we anticipate that our route to market will be through what’s called a 505(b)2 mechanism. That’s important because if ultimately acceptable, regulatory translation is much simpler than for a new drug and clinical trials timelines are usually shorter.
It’s an accelerated regulatory approval mechanism which acknowledges that these are drugs that are already used and the concentrations in the blood for safety and efficacy are understood. We anticipate that we’ll have completed phase one for the rifapentine LAI by the end of 2026.
SR Unitaid have been supportive of the stages we need to go through and we’re funded all the way to human trials, which is fantastic. However, our funding stops when we’ve done the proof of concept in humans. The next stage will be a tech transfer at which we are aiming for a development partner to take over what we’ve done to turn it into a medicine that can be distributed widely.
We’re very keen to have a number of partners given access to the output IP and the technology. They can then develop their version of the of the products and get them out to clinics and communities as fast as possible.
AO Avoidance of the cold chain with is a critical aim for our development programme, and we’ve put a lot of emphasis on avoiding the need for refrigeration.
MPP is an excellent partner because you have history and experience in this space. It’s about the trust that has been built up over the years. The experience that MPP has built up is clearly key, including IP knowledge and transfer at the end of the process to development partners. One of the major benefits of MPP is that it works with access in mind, and they were very flexible and supportive.
[1]https://www.theglobalfund.org/en/tuberculosis
[2]Swindells S, Ramchandani R, Gupta A, et al. “One Month of Rifapentine plus Isoniazid to Prevent HIV‑Related Tuberculosis.” N Engl J Med. 2019;380(11):1001‑1011.
[3]Vermeulen M, Scarsi KK, Furl R, Sayles H, Anderson MJ, Valawalkar S, Kadam A, Cox SR, Mave V, Barthwal M, Schutz C, Ward A, Dountio Ofimboudem J, Meintjes G, Rannard S, Owen A, Swindells S. Patient and provider preferences for long-acting TB preventive therapy. IJTLD Open. 2025 May 12;2(5):276-283. doi: 10.5588/ijtldopen.24.0670. PMID: 40365033; PMCID: PMC12068448.
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The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to and facilitate the development of life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups, and other stakeholders to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations.
To date, MPP has signed agreements with 22 patent holders for 13 HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, a cancer treatment, four long-acting technologies, a post-partum haemorrhage medicine, three oral antiviral treatments for COVID-19 and 16 COVID-19 technologies.
MPP was founded by Unitaid, which continues to be MPP’s main funder. MPP’s work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC), Government of Canada, the World Intellectual Property Organization (WIPO) and the Government of Flanders. MPP’s activities in COVID-19 are undertaken with the financial support of the Japanese Government, the French Ministry for Europe and Foreign Affairs, the German Agency for International Cooperation, and SDC.