Second successful Phase I trial for BioVersys

The analysis of preliminary, blinded data show a very favorable safety, tolerability and pharmacokinetic profile of BVL-GSK098 at therapeutically effective doses in healthy volunteers. BVL-GSK098 was developed from BioVersys’ award winning Transcriptional Regulatory Inhibitory Compounds (TRIC) platform in a successful private-public partnership with GSK, the Institut Pasteur de Lille and University of Lille. This is a major milestone of the TRIC-TB project that continues to receive funding from the EU IMI-JU2 programme under the AMR Accelerator umbrella.

Dr. David Barros-Aguirre VP and Head of Tuberculosis Research Unit, Global Health R&D, GSK, commented: “GSK is committed to the discovery of shorter, simpler and safer treatments for tuberculosis. The TRIC-TB programme is an outstanding example of a public-private partnership between academia, biotech and the pharmaceutical industry which, with funding from the EU IMI-JU2 programme, is enabling us to work together and deliver innovative treatment options for patients.”

Dr. Marc Gitzinger, Chief Executive Officer and founder of BioVersys, added: “As the need for novel anti-tuberculosis therapies increases following the deleterious impact of COVID-19 on TB patients, we are delighted to see the excellent safety data coming out of our FiH studies of BVL-GSK098, and eagerly anticipate initiating a Phase 2a clinical trial with BVL-GSK098 and Eto later this year. Aside from the value to patients, the TRIC-TB program is a clear example of how public-private partnerships successfully enable biotech companies to deliver innovation, even in challenging indications such as tuberculosis. The combination of academic excellence provided by our partners in Lille, large industry in the form of GSK, the capacities of BioVersys and the public funding from EU IMI, was instrumental in achieving this milestone.”

A novel fast acting TB agent

Ethionamide (Eto) and prothionamide (Pto) are recommended by the World Health Organization (WHO) for use as second-line agents in the treatment of drug-resistant pulmonary TB and TB meningitis. Despite their usefulness as a TB drugs, Eto/Pto cause dose-dependent adverse events that negatively impact treatment adherence. Based on pre-clinical data, it is expected that BVL-GSK098 could lower the efficacious human oral dose of Eto by at least 3-fold, with the potential to significantly minimize dose-dependent side effects and improve patient compliance allowing to finally tap into the full potential of this 60 year old drug. TRIC-TB has the potential to deliver a novel, fast acting TB agent potentially replacing isoniazid in TB therapy.

(Press release / SK)