New Consortium Aims To Develop “Pan-TB” Treatment Regimen
Abdul Rasyid, a TB MDR patient, works as a motivator in the inpatient TB MDR ward at the Persahabatan Hospital in Jakarta, Indonesia

While health leaders battle a global outbreak of a dangerous new virus, a consortium of partners is entering the fight against one of humankind’s oldest infectious diseases, tuberculosis.

A group of philanthropic, non-profit, and private sector organizations on Thursday launched a collaboration to accelerate development for a “pan-TB” treatment regimen to treat drug-sensitive and drug-resistant forms of the deadliest infectious disease in the world.

The first-of-its kind Project to Accelerate New Treatments for Tuberculosis (PAN-TB collaboration) aims to develop safe treatment regimens that have little to no drug resistance and advance them through phase 2 clinical trials – universal regimens that can treat multiple different strains of TB.

“The development of a regimen that can treat both drug-sensitive and drug-resistant tuberculosis could be a game changer for how the world addresses TB and growing antimicrobial resistance,” said Penny Heaton, chief executive officer of the Bill & Melinda Gates Medical Research Institute, a founding member of the consortium, in a press release

The need for new treatment options is high. There exists no single treatment available to treat all forms of TB. Only three new drugs have been approved for the treatment of TB in the past 50 years – bedaquiline, delamanid, and pretomanid, which was just approved in August 2019 by the United States Food and Drug Administration.

In 2018, the World Health Organization estimated that there were 10 million new cases of TB and almost 1.5 million deaths. It’s estimated that there were 500,000 cases of drug-resistant TB, in which almost half of the patients died.

Currently, even the easiest to treat strain of TB – known as drug-sensitive or drug-susceptible TB – requires a regimen of four core drugs taken for at least 6 months.

Despite being known as the easiest to treat form of active TB, the current WHO-recommended regimen for drug-sensitive TB still consists of a grueling 6 month treatment – a combination of four different antibiotic pills taken daily for two months, followed by another four months of taking two antibiotics per day.

But even this regimen is not sufficient to treat forms of drug-resistant TB, or strains resistant to any of the four core drugs. These deadly strains require different treatment courses – which may contain more than 5 different drugs and take up to two years to complete. It’s estimated such drug-resistant TB strains killed 230,000 people in 2017.

However, to diagnose drug-resistant TB, patients must undergo additional testing.

The new PAN-TB initiative aims to develop regimens that can be used to cure both drug-sensitive and drug-resistant strains of TB, cutting down on the need to test for drug-resistance and potentially giving patients safer, shorter, and simpler treatment options.

A spokesperson for the consortium told Health Policy Watch that the exact drug candidates for the phase 2 trials are still being identified.

However, the spokesperson added that the Bill and Melinda Gates Foundation has committed grant funds for non-clinical studies to identify promising compounds for the treatment course. The Bill and Melinda Gates Medical Research Institute will fund and lead clinical studies in the partnership.

The pharmaceutical partners include Evotec, GlaxoSmithKline, Johnson & Johnson, and Otsuka Pharmaceuticals, and will contribute in-kind resources, including providing access to a library of candidate compounds, and dedicating scientific and technical expertise to the initiative.

The global PAN-TB collaboration aims to link up with another TB drug development initiative launched just a few weeks prior on 29 January, the European Accelerator of Tuberculoses Regime (ERA4TB) project, a 30-partner initiative funded by the European Commission. ERA4TB aims to accelerate preclinical identification of promising compounds, while PAN-TB aims to take such preclinical discoveries through to the end of costly phase 2 clinical trials.

Image Credits: Bill & Melinda Gates Foundation/Prashant Panjiar.