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BioVersys, TASK and GSK receive 2.7 million euro from EDCTP for Phase 2a clinical trial

Basel, Switzerland. Februar 25, 2021. 09:00 CEST

BioVersys and consortium partners TASK Foundation and GSK have been awarded 2.7 million Euro from 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 have been awarded 2.7 million Euro 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 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 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, 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 the potential 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 welltolerated dose on tuberculosis. This in an effort to find a combination of BVL-GSK098 and lowdose Eto that is best tolerated.”

Dr. Glenn Dale, Chief Development Officer of BioVersys: “We are very pleased to receive the award from the EDCTP, as it will allow to confirm the promising data shown for bEto in vitro and in animal efficacy models for the first time in TB patients. The direct comparison of bEto to INH in this EBA proof of concept trial, will enable to elucidate the full potential of bEto as a fast-acting drug combination to be added to both drug-sensitive (DS) and MDR/XDR drug regimens.”

Dr. David Barros-Aguirre VP and Head of Tuberculosis Research Unit, Global Health R&D, GSK: “GSK is committed to the discovery of novel treatments for tuberculosis, an area of high unmet medical need. The bEto-TB project gives us the opportunity to clinically validate the use of a selective booster of the anti-TB therapy ethionamide discovered by BioVersys and GSK to reduce the efficacious dose of ethionamide. We hope that a reduction in the dose of ethionamide will improve tolerability, lead to greater therapeutic benefit and expand the use of ethionamide in future TB regimes.”

Dr. Marc Gitzinger, CEO and co-founder of BioVersys: “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.”