BioVersys is developing, BVL-GSK098 in collaboration with GSK for the treatment of multi-drug resistant tuberculosis infections. The drug candidate has received a Qualified Infectious Disease Product designation from the U.S. for oral use in the treatment of pulmonary tuberculosis. This milestone paves the way for the first in human trials.
Based in Basel, BioVersys is a privately owned, multi-asset Swiss pharmaceutical company focusing on research and development of small molecules for multidrug-resistant bacterial infections. The clinical candidate BVL-GSK098 originates from BioVersys’ Transcriptional Regulator Inhibitory Compound (TRIC) platform in with GSK, the Pasteur Institute Lille and the University of Lille (with the groups of Nicolas Willand, Alain Baulard and Benoit Deprez) with previous financial support from the Wellcome Trust.
The startup has today announced that BVL-GSK098 in a fixed combination with ethionamide (ETH) has received Qualified Infectious Disease Product (QIDP) designation from the U.S. FDA for oral use in the treatment of pulmonary tuberculosis (TB). QIPD status automatically gives priority review designation to the first application or efficacy supplement submitted for a specific drug product and indication for which QIDP designation is granted. Subject to some statutory limitations, a drug that is designated as a QIDP will receive a 5-year extension to any exclusivity for which the application qualifies upon approval.
First in Human trials launching soon
BVL-GSK098 has completed GLP toxicology studies and is being prepared to enter First in Human (FiH) clinical trials in 2H 2020. The development of BVL-GSK098 has also been supported since May 2019 by the Innovative Medicines Initiative 2 Joint Undertaking (IMI2 JU) through a grant of €6.92 million.
The World Health Organization (WHO) considers ETH a crucial pillar of TB treatment, especially against MDR (multidrug-resistant) and XDR (extensively drug-resistant) strains. BVL-GSK098 boosts the in vitro and in vivo activity of the well-known anti-tubercular pro-drug ETH, resulting in an unprecedented increase of ETH efficacy in vivo. This boosting of activity would allow for lower efficacious doses of ETH in human anti-TB treatments. It is also predicted to result in a reduction in dose dependent adverse effects in TB patients. Data further shows that BVL-GSK098 overcomes pre-existing resistance mechanisms in Mycobacterium tuberculosis against ETH by employing novel bioactivation pathways for ETH.
Marc Gitzinger, CEO and co-founder of BioVersys: “Tuberculosis is still the single biggest infectious disease killer of our time and novel treatment regimens are urgently needed. The receipt of QIDP designation from the FDA is an important step forward and validation of BVL-GSK098 and our TRIC-TB program. We remain committed to developing innovative and life-saving AMR treatments for exceptionally high unmet medical needs.”The TRIC Project aims progress clinical candidates that potentiate the efficacy of and reverse the resistance to the anti-tubercular pro-drug ethionamide (ETH).
(Press release / RAN)
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