Bioversys completes Phase I clinical trials for better tuberculosis treatments

BioVersys AG, a privately-held clinical stage, multi-asset Swiss pharmaceutical company focusing on research and development of small molecules for multidrug-resistant bacterial infections with applications in antimicrobial resistance (AMR) and targeted microbiome modulation, announced today the successful completion of Phase I clinical trials of BVL-GSK098.

• BVL-GSK098 was 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. The compound represents a totally new concept of overcoming resistance by boosting the activity of an existing antibiotic.
• 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.

The analysis of preliminary, blinded data from these studies show a very favorable safety, tolerability and pharmacokinetic profile of BVL-GSK098 at therapeutically effective doses in healthy volunteers.

Dr. Glenn E. Dale, Chief Development Officer of BioVersys: “We are pleased by the favorable safety profile of BVL-GSK098 at the doses studied in our clinical trials. The positive data will allow us to rapidly transition to a Phase IIa clinical study in patients with pulmonary TB later this year to test the Early Bactericidal Activity (EBA), safety, tolerability and pharmacokinetics of ethionamide (Eto) alone and in combination with BVL-GSK098.”

Dr. Pierre Meulien, Executive Director of the Innovative Health Initiative (IHI), which manages Innovative Medicines Initiative (IMI) projects: “This fantastic achievement by the IMI project TRIC-TB highlights the ability of public-private partnerships to make progress in challenging areas such as tuberculosis, where we urgently need new and better treatment regimens. It is also an important contribution to the goals of IMI’s wider AMR Accelerator programme, which has a strong focus on tuberculosis.”

Dr. David Barros-Aguirre VP and Head of Tuberculosis Research Unit, Global Health R&D, GSK: “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: “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.”

About TRIC-TB Project
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. Eto/Pto are prodrugs and their antibacterial activity can be linked to the level of bioactivation inside Mycobacterium tuberculosis (Mtb). The clinical candidate BVL-GSK098 acts on transcriptional regulators of Mtb, stimulating novel bioactivation pathways for Eto resulting in an increase of Eto efficacy, while simultaneously overcoming Eto resistance and keeping potent activity on MDR strains, including to a vast majority of isoniazid-resistant strains. BVL-GSK098 renders Eto rapidly bactericidal and reduces the emergence of Eto resistance development in vitro and in vivo. 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. With the completion of the Phase 1 a major milestone of the TRIC-TB was achieved. Follow TRIC-TB on Twitter @TRIC_TB.

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 853800. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EPFIA.