A message from the CEO and Chairman of the Board
This past year has been extremely challenging. The COVID-19 pandemic, which spanned virtually the entirety of 2020, continues to take a severe toll on lives and livelihoods around the world. In recognition of this once in a lifetime challenge, we stood in solidarity with other tuberculosis (TB) research leaders on World TB Day this past March in the fight against COVID-19—a stance that is just as critical today as it was almost a year ago.
In this year’s report, Gaining Ground, we detail the progress made under uniquely challenging conditions in developing new treatments that aim to improve the lives of TB sufferers around the world. The fact that we have managed to sustain momentum throughout this 20th anniversary year of the TB Alliance is a tremendous tribute to the dedication, capabilities, and hard work of our partners and staff.
Our treatment for highly drug-resistant forms of TB continued to reach major milestones toward global accessibility. The first regulatory approval in 2019 by the US Food and Drug Administration was followed this past year by approvals from the European Commission and Drug Controller General of India, as well as incorporation into World Health Organization (WHO) guidelines. Operational research programs are now underway in 9 countries, with many more expected to join in 2021 through programs like LIFT-TB, supported by the Republic of Korea through the Global Disease Eradication Fund. We profoundly thank our many partners and donors without whom this unprecedented rate of progress for a new TB drug could never have been achieved. We were also profoundly honored by the Prix Galien Award for Best Pharmaceutical Agent that was bestowed on pretomanid last year.
Despite the numerous headwinds presented by the COVID-19 pandemic, including lockdowns, travel restrictions, closing of TB hospitals, and diversion of TB staff, our three late-stage studies (Nix-TB, ZeNix, and SimpliciTB) have continued to progress well. Enrollment in the studies was completed in 2020 and top-line results will be available in 2021.
Similarly, multiple challenges arose for compounds in earlier stages of clinical development. Our progression of the drug candidates TBI-223, TBAJ-587, and TBAJ-876 has only been possible because of rapid flexibility on choosing Phase 1 sites that could operate through the COVID-19 pandemic, as well as our engagement with the Innovative Medicines Initiative (IMI). The development of TBA-7371 and sutezolid has also continued through a close partnership with the Gates Medical Research Institute.
"Despite the numerous headwinds presented by the COVID-19 pandemic, our research has continued to progress well."
Our earlier stage research has similarly progressed despite the challenges of COVID-19—this includes our internal TB discovery programs, advances in our National Institutes of Health (NIH) Centers of Excellence for Translational Research program, as well as new research into new treatments for non-tuberculosis mycobacteria with support from the Cystic Fibrosis Foundation.
Our long-term vision, which is more urgent than ever in the wake of COVID-19, is a days- to weeks-long therapy that would serve to lift immense burdens from patients and health care systems alike. We are actively exploring new ways to achieve this beyond the conventional paradigms of antibiotic drug discovery. This includes taking advantage of advances in artificial intelligence and host-directed therapies, such as immunotherapeutics and therapeutic vaccines. We must continue to push the boundaries of scientific advances in fighting TB.
None of these achievements would have been possible without the dedication and determination of our partners, donors, stakeholders, and above all, our clinical trial participants. It is because of this engagement that we can envision a world in which the time it takes to cure TB is measured in days, not months, and ultimately this disease is vanquished.