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BioVersys, TASK et GSK ont reçu 2,7 M€ d’EDCTP pour la phase 2 de leurs essais cliniques

Postée le 26 février 2021

BioVersys, TASK and GSK receive 2.7 million Euro 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 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.”

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