BioVersys and consortium partners obtain €2.7 million grant

BioVersys AG is a privately owned, multi-asset Swiss pharmaceutical company focusing on research and development of small molecules for multidrug-resistant bacterial infections with applications in Anti-Microbial Resistance (AMR) and targeted microbiome modulation. 

The candidate BVL-GSK098 has been developed from BioVersys’ award-winning Transcriptional Regulatory Inhibitory Compounds (TRIC) platform in a successful collaboration with GSK, the Institut Pasteur de Lille and the University of Lille. BVL-GSK098 is currently being studied in First in Human Phase 1 clinical trials, supported by the IMI2 AMR Accelerator from the EU (TRIC-TB Project), which is anticipated to be completed in the second half of 2021. 

BVL-GSK098 in a fixed combination with ethionamide (Eto) has also received Qualified Infectious Disease Product designation from the U.S. FDA in June 2020, for oral use in the treatment of pulmonary tuberculosis (TB), making BVL-GSK098 eligible for FDA priority review, Fast Track designation, and a five-year extension of market exclusivity upon approval. 

The World Health Organization considers Eto a crucial pillar of TB treatment, especially against multidrug-resistant and extensively drug-resistant strains. BVL-GSK098 boosts the activity of Eto (bEto), resulting in an increase of Eto efficacy by at least three-fold in vivo, which could allow for lower efficacious doses of Eto in human anti-TB treatments with a reduction in dose-dependent adverse effects in TB patients. Furthermore, preclinical data shows that BVL-GSK098 overcomes pre-existing resistance against Eto, isoniazid (INH) and rifampicin in Mycobacterium tuberculosis, by employing novel bioactivation pathways for Eto. Therefore, a bEto combination has the potential to not only be part of an effective MDR-TB regimen but also the potential to replace INH in first-line TB regimens.

Today a consortium of BioVersys, the TASK Foundation and GSK have been awarded 2.7 million Euro funding from the EDCTP to conduct a Phase 2a (TB) clinical trial study with BioVersys’ clinical candidate BVL-GSK098 in combination with Eto.

Marc Gitzinger, CEO and co-founder of BioVersys says: “We are delighted and grateful to receive this grant from the EDCTP, supporting the further development of BVL-GSK098 in combination with Eto. bEto is an innovative combination therapy that is in-line with the global need to conserve our current antimicrobial therapeutic armory, by reinvigorating a WHO’s essential medicine, Eto, a valuable weapon against DS and MDR-TB. We look forward to continuing to work with GSK on this project and warmly welcome the opportunity to work with TASK, a world-leading clinical trials center for TB.”

(Press release)