TB Alliance 2012Annual Report

» Download the full report

Dr. Mel Spigelman
CEO and President

Dr. Bruce Carter
Chairman of the Board

Dear donors, stakeholders, partners, and patients,

This year has been another of significant change and achievement. Multiple waves of innovation are rippling through our once-stagnant TB drug development world. With our dedicated partners and new scientific approaches, we are accomplishing more than ever in a fraction of the time that would have been necessary a few years ago.

Positive results from the first regimen trial of PaMZ led to the initiation of NC- 002 — the first study that looks to realize the promise of treating drug-sensitive TB and MDR-TB patients with the same regimen. With the completion of patient treatment in REMox TB, we are closer to the first new product to shorten the treatment of drug-sensitive TB in almost 50 years. Meanwhile, we continue to identify even shorter potential regimens, ones that could treat TB in as little as six weeks and be used without concerns of pre-existing resistance.

We have built new partnerships in the discovery space and ramped up work to prepare for the launch of a moxifloxacincontaining four-month TB regimen. We are now collaborating more closely than ever with TB diagnostic scientists and developers to ensure new products will have their greatest impact and reach patients everywhere.

With the continued support of partners, donors, and stakeholders, we are poised to realize the promise of a revolution in TB care through the introduction of novel products. This revolution will be powered by innovation, leadership, and collaboration — all attributes to which we continually aspire.


Racing Against a Killer Pandemic

Tuberculosis (TB) is a global pandemic killing nearly 1.5 million a year. The proliferation of drug-resistant TB has heightened the need for dramatically shorter and simpler drug regimens to treat and control the disease. Conquering this ancient killer is not possible without new treatments.

Today, the global pipeline of promising new TB drugs is larger than ever and transformative treatment is within reach. TB Alliance and partners are realizing this promise by developing the most beneficial TB regimens. Through innovation, we are working to bring faster, better, and affordable TB drugs to all.

In 2012, TB was responsible for
MORE THAN 5 TIMES as many deaths as all natural disasters combined


Sanofi and TB Alliance Announce Collaboration to Accelerate New Treatments Against Tuberculosis

Goal is to select novel clinical development candidates to help stop the global pandemic

TB Alliance Launches Combination Drug Trial

Establishes New Pathway to TB and MDR-TB Treatment. Goal is to find new treatment that takes months, not years, and cures multiple forms of tuberculosis.

Trial Signals Major Milestone in Hunt for New TB Drugs

Lancet paper finds novel drug regimen could be more effective than existing treatments; TB Alliance's trial to test drugs in combination saves years in research time

Read more TB Alliance news


Developing Tomorrow's Treatments TodayThe new unit of care is the regimen

Tuberculosis must be treated with a combination of drugs. Therefore, in order to truly revolutionize TB therapy, regimens with multiple new agents are needed. TB Alliance and partners have established a game-changing R&D paradigm, allowing new TB drug combinations to be tested and brought to market more quickly than ever before. This new approach to regimen development powers our most recently launched and completed clinical trials of novel drug combinations.

To scientists, these flagship studies represent the cutting edge of TB drug development. To public health professionals, they represent an opportunity to develop the cheaper, simpler, and more effective tools needed to control and reverse the TB pandemic. To those affected by TB, they represent new promise for health and prosperity, everywhere.

NC-001First regimen trial yields positive results

In 2012, the results of the first novel TB drug combination trial NC-001 (New Combination 1) were published in The Lancet. These findings revealed that the experimental regimen PaMZ (PA-824 + moxifloxacin + pyrazinamide) killed more bacteria than today's TB treatment through the first two weeks of treatment.

This promising regimen may treat TB and many MDR-TB patients with the same totally oral treatment, thereby eliminating the need for injectable drugs. In doing so, it could reduce the length of some MDR-TB treatment by 80% and its cost by as much as 90%.

NC-002First combined TB & MDR-TB trial launches

On World TB Day 2012, TB Alliance launched the NC-002 (New Combination 2) trial to test PaMZ for two months in TB and MDR-TB patients — the first trial to test a single regimen's ability to treat both drug-sensitive TB and MDR-TB. This trial is currently enrolling patients in multiple sites, helping to enhance clinical trial capacity for future regimen-development efforts. Positive results from this study would set the stage for pivotal Phase III registration trials of the PaMZ regimen.

NC-003Second-generation regimens enter the clinic

TB Alliance uses a robust preclinical regimen-identification program to explore promising next-generation drug combinations. In 2012, TB Alliance also launched NC-003 (New Combination 3), the first clinical trial of second-generation novel regimens identified through this program. Four different second-generation regimens with the potential to further shorten treatment of TB, including MDR-TB, are being studied in this two-week trial.

Promise in the PipelineNew partnerships will identify tomorrow's cures

The path to new TB drug regimens begins early on in drug discovery. To speed improved cures to patients, it is critical to stock the clinical development pipeline with promising new compounds, identify exciting drug combinations, and test them early in the development process. Preclinical testing of the PaMZ regimen allowed TB Alliance to rapidly advance the regimen into clinical trials.

This year, working with Johns Hopkins University on our preclinical combination-identification program, we discovered promising drug regimens. Using preclinical models, we have already identified regimens with the potential to reduce TB treatment to less than two months. Additionally, we have advanced a nextgeneration nitroimidazole, TBA-354. This compound, discovered in partnership with University of Auckland and University of Illinois at Chicago, is slated to enter clinical development in 2013.

Voices of TB: The people behind the promise.

Realizing the promise of better, faster-acting, and affordable TB drugs requires a global network of partners, each pushing forward that vision. TB Alliance collaborates at every level to help drive innovation through partnership — and in the process, provide improved TB regimens to those that need them.

  • Reaching Patients

    In 2012, the TB Alliance and its partners completed enrollment and treatment of patients in the REMox TB trial. This trial is testing a four-month moxifloxacin-containing regimen in drug-sensitive TB patients. If clinical trial results are positive, registration would be sought by 2014 in conjunction with our partner, Bayer HealthCare.

    This new regimen would offer a shorter TB treatment for millions suffering around the world.

    In preparation for results from the REMox TB trial, TB Alliance is augmenting the project's focus — from science and clinical trials to access — to ensure that an approved and beneficial product will be available as soon as possible to those in need. We have redoubled efforts to engage with high-TB burden countries, donors, the World Health Organization, and technical assistance agencies on issues from country and global decision making to uptake planning and product presentation.

  • TB treatment is often provided free of charge, but patients still pay the price.

    A study conducted by the Liverpool School of Tropical Medicine, the National Institute of Medical Research in Tanzania, and BRAC in Bangladesh, in collaboration with TB Alliance, has documented the impact of TB treatment on patients. In the last two months of therapy, the economic toll of a patient's disease is equivalent to 90% of their usual earnings. Lost income and travel costs to reach the health center are both high.

    A shorter regimen like those tested in the REMox TB trial would eliminate two months of these costs, thus greatly reducing a patient's burden - and helping to stop the cycle of TB and poverty.

  • For new regimens to have maximal impact
    TB diagnostics must evolve in concert.

    For new regimens to have maximal impact, TB drugs and diagnostics must evolve in concert. Healthcare systems need tools to properly and accurately diagnose patients with TB. Simplified, low-cost drug-susceptibility testing would allow patients to be treated only with drugs to which they are sensitive — a modern standard too rarely used in TB treatment.

    In 2012, TB Alliance signed a Memorandum of Understanding with the Foundation for Innovative New Diagnostics (FIND). This agreement paves the way for closer collaboration, priority setting, and information sharing. Through this partnership, we are developing a target product profile to inform diagnostics developers as to what tools are needed to complement new drug regimens in development. Such coordination will maximize the global impact of both new TB drugs and diagnostics.

    • TB Alliance convened its third Community Engagement forum in 2012. This forum, the largest to date, included participants from all sites with Community Engagement (CE) programs, including those sites sponsored by the National Institutes of Health AIDS Clinical Trial Group, advocates, and other stakeholders, as well as members of the Global TB Community Advisory Board and CPTR Stakeholder and Community Engagement Workgroup. Topics of this year's forum focused on best practices and the challenges of implementing CE activities for TB drug trials, monitoring and evaluation of CE activities, good participatory practice, and advocacy. These forums bring together a unique set of voices in the TB research process, enabling an enriching exchange of perspectives and insight on how to advance TB control and research.
    • Jane Ong'ang'o, Study and CE Coordinator, Kenya Medical Research Institute (KEMRI) - Nairobi, Kenya
    • Taharqa Elnour, CE Coordinator, TASK Applied Science - Cape Town, South Africa
    • Nomampondo Barnabas, Perinatal HIV Research Unit (PHRU) - Soweto, South Africa
    • Dr. Ali Said, Study Coordinator, Ifakara Health Institute - Bagamoyo, Tanzania
    • David Greeley, Senior Vice-President of External Affairs, TB Alliance - New York, USA
    • Gauta Mopereo, CE Coordinator, WITS Health Consortium - Johannesburg, South Africa
    • Modiehi Rakgokong, CE Coordinator, Perinatal HIV Research Unit (PHRU) - Klerksdorp, South Africa / Rabson Mmari, CE Coordinator, Kibong'oto National TB Hospital, Moshi, Tanzania
    • Renaud Boulanger, University of Toronto - Toronto, Canada
    • Vincent Chikuni, Community Advisory Board (CAB) Chair, Madibeng Centre for Research (MCR) - Brits, South Africa
    • John Mdluli, Community Engagement Manager, The Aurum Institute - Tembisa, South Africa
    • Erica Sanga, CE Coordinator, Mbeya Medical Research Programme (MMRP) - Mbeya, Tanzania
    • Nombuyiselo Tshandu, CE Coordinator, WITS Health Consortium - Johannesburg, South Africa / Laia Ruiz Mingote, Planeta Salud - Madrid, Spain
    • Murial Ross, Community Advisory Board Member - Delft, South Africa
    • Malebogo Keogatile, Community Advisory Board Member - Perinatal HIV Research Unit (PHRU) - Klerksdorp, South Africa
    • Sara Mulera, CE Coordinator, Kenya Medical Research Institute (KEMRI) - Nairobi, Kenya / Gloria Nyaulingo, CE Coordinator, Ifakara Health Institute - Bagamoyo, Tanania / Mr. Panziso, CAB Chair, Delft, South Africa
    • 2012 Community Engagement Forum Participants
    • Bernice Isaacs, Suraya Beukes, Michelle Evreva, UCT Lung Institute - Cape Town, South Africa