BioVersys, TASK and GSK receive €2.7 million from EDCTP for Phase 2a clinical trial
BVL-GSK098 AND ETHIONAMIDE COMBINATION IS BEING DEVELOPED FOR THE TREATMENT OF MULTI-DRUG RESISTANT TUBERCULOSIS INFECTIONS
BioVersys and consortium partners TASK Foundation and GSK have been awarded €2.7 million from the European and Developing Countries Trial Partnership (EDCTP) for the further development of BVL-GSK098 with ethionamide in a Phase 2a tuberculosis clinical trial study.
BioVersys AG, 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, announced today that a consortium of BioVersys, the TASK Foundation, and GSK has be
awarded €2.7 million in funding from the EDCTP to conduct a Phase 2a tuberculosis (TB) clinical trial study with BioVersys' clinical candidate BVL-GSK098 in combination with ethionamide (Eto).
• 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 (FiH) Phase 1 clinical trials, supported by the IMI2 AMR Accelerator from the EU (TRIC-TB Project), which is anticipated to be completed in 2H 2021. BVL-GSK098 in a fixed combination with Eto also received Qualified Infectious Disease Product designation from the U.S. FDA in June 2020, for oral use in the treatment of pulmonary tuberculosis, 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 (WHO) considers Eto a crucial pillar of TB treatment, especially against MDR (multidrug-resistant) and XDR (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, that 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 preexisting 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 to replace INH in first-line TB regimens.
Prof. Andreas Diacon, Founder, Director & CEO at TASK: “TASK is excited to participate in this new EDCTP funded research project, particularly in the many potential uses for this 2-drug combination, and the opportunity to collaborate with BioVersys and GSK. We hope to see in this Early Bactericidal Activity (EBA) trial how a new anti-TB molecule, BVL-GSK098
augments the activity of the well-established second-line drug ethionamide at a lower and well-tolerated dose on tuberculosis. This is in an effort to find a combination of BVL-GSK098 and low-dose Eto that is best tolerated.”