TB drug wins “Best Pharmaceutical Agent” prize

31 October 2020

Pretomanid - a TB drug that has finally been approved for use after 20 years of development - has won a prize!

Dr Julio Ortiz Canseco from the TB clinical trials microbiology team at the UCL Centre for Clinical Microbiology

The  TB Alliance won the “Best Pharmaceutical Agent” prize at the Galien Foundation USA awards held on 29 October 2020, for it’s development of the anti-tuberculosis (TB) drug Pretomanid.

TB is treated with multiple drugs, in order to kill bacteria in different phases of growth or body compartments, and to reduce the development of drug resistance. Nevertheless, resistance is rising, and strains resistant to the two main first-line drugs (MDR-TB) or to first and second-line drugs (XDR-TB) are spreading.

Most drugs used for treating TB were identified and approved many years ago, and developing new drugs is slow and expensive.  Most recently, Bedaquiline was approved in 2012 and Delamanid in 2013 for treating MDR-TB.

Pretomanid is a drug that was first identified as a drug candidate 20 years ago, and has gone through sixteen Phase 1 and phase 2 trials (that assess safety and efficacy), and three phase 3 trials (that compare efficacy to the existing treatments) – two of which are ongoing. In particular, the Nix trial showed that Pretomanid – in combination with the drugs Bedaquiline and Linezolid (BpaL) – is effective in a 6 month regimen for XDR-TB, which is notoriously hard to treat, with courses previously likely to last 18-24 months. This has led to limited-use authorisations by the FDA In the US in August 2019 and the EMA in Europe in July 2020.

Several of the past and ongoing trials including Pretomanid have been / are being supported by UCL expertise in clinical trials statistics by the MRC Clinical Trials Unit at UCL, and specialist TB microbiology by the UCL Centre for Clinical Microbiology based at the Royal Free Hospital.

The TB Alliance is a non-profit Product Development Partnership, hosted by the Medical Research Council of South Africa, NIH, the Bill and Melinda Gates Foundation, the Wellcome Trust, and the UK Department for International Development.

The prestigious Prix Galien is awarded by the Galien Foundation, a non-profit organization named after the hugely influential 2nd century CE Roman physician Galen.