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BioVersys Receives QIDP Designation from the U.S. FDA for the Development of a fixed combination of BVL-GSK098 and ETH

BVL-GSK098 is being developed for the treatment of multi-drug resistant tuberculosis infections

Basel, Switzerland. June, 23rd, 2020. 09:00 CEST

BioVersys develops BVL-GSK098, in collaboration with GSK, as an entirely new mechanism to potentiate and overcome resistance of ethionamide in tuberculosis.

BioVersys AG a privately owned, multi-asset Swiss pharmaceutical company focusing on research and development of small molecules for multidrug-resistant bacterial infections, announced today that its clinical candidate 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.

BVL-GSK098 originates from BioVersys’ award winning Transcriptional Regulator Inhibitory Compound (TRIC) platform in a successful collaboration with GSK, the Pasteur Institute Lille and University of Lille (with the groups of Nicolas Willand, Alain Baulard and Benoit Deprez) with previous financial support from the Wellcome Trust. 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 and is predicted to result in a reduction in dose dependent adverse effects in TB patients. Furthermore, data shows that BVL-GSK098 overcomes pre-existing resistance mechanisms in Mycobacterium tuberculosis against ETH by employing novel bioactivation pathways for ETH.

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