A decision by US regulators is set to speed up reviews of a potential new TB drug being developed by IMI’s TRIC-TB project.
Tuberculosis is a major public health threat. In 2017 alone, over 10 million people developed active TB and it killed 1.7 million, making it one of the top 10 causes of death worldwide. Treatment is via a six-month course of four antibiotics.
IMI’s TRIC-TB project was set up to advance the development of molecules that could boost the infection-fighting ability of the anti-TB drug Ethionamide. The compounds work by interfering with the systems that control gene activity in the TB bacteria. Previous studies have shown that they are able to boost the efficacy of Ethionamide three-fold.
Now, the US Food and Drug Administration (FDA) has given Qualified Infectious Disease Product (QIDP) designation to one of the compounds (BVL-GSK098) in a fixed combination with Ethionamide for the treatment of pulmonary TB.
QIDP designation is given to antibacterial or antifungal drugs designed to treat serious or life-threatening infections. Crucially, QIDPs are eligible for priority and fast track review by the FDA. This will therefore help TRIC-TB to speed up the development of the compound.
Ultimately, if clinical trials are successful, BVL-GSK098 could allow doctors to reduce the dose of Ethionamide typically given to patients, something that would also reduce the side effects associated with the drug.
‘Tuberculosis is still the single biggest infectious disease killer of our time and novel treatment regimens are urgently needed,’ said Dr Marc Gitzinger, CEO and co-founder of BioVersys, which is developing BVL-GSK098 in collaboration with GSK. ‘The receipt of QIDP designation from the FDA is an important step forward and validation of BVL-GSK098 and our TRIC-TB programme. We remain committed to developing innovative and life-saving AMR treatments for exceptionally high unmet medical needs.’
‘The QIDP designation from the FDA recognises this high unmet need and represents an important step in our collaboration with BioVersys to develop BVL-GSK098, within the IMI2 TRIC-TB programme, as a potential treatment to optimise the beneficial effects of Ethionamide,’ added Dr David Barros-Aguirre VP and Head of Tuberculosis Research Unit, Global Health R&D at GSK.