Basel, Switzerland. January 31, 2023, 9am CET
BioVersys AG announces first patient dosed in Phase 2a clinical trial with BVL-GSK099
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, that the first patient has been dosed in Phase 2a clinical trial with BVL-GSK098.
· BVL-GSK098 is a small molecule 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 and significantly potentiating the activity of an existing antibiotic, ethionamide (Eto) or prothionamide (Pto), for the treatment of tuberculosis (TB).
· In recently completed Phase 1 studies, BVL-GSK098 was generally safe and well tolerated, and showed a favorable pharmacokinetic profile at therapeutically effective doses in healthy volunteers.
· Today’s announcement is a major milestone of the bEto-TB project, which is funded by the European & Developing Countries Clinical Trials Partnership (EDCTP2 programme), supported by the European Union.
Dr. Glenn E. Dale, Chief Development Officer of BioVersys: “Following the very promising safety profile in Phase 1, we are excited to be testing BVL-GSK098 for the first time in patients, with its new concept of overcoming resistance by boosting activity of Eto against Mycobacterium tuberculosis. This Early Bactericidal Activity (EBA) Phase 2a study will test the efficacy, safety, tolerability and pharmacokinetics of BVL-GSK098 in combination with various doses of Eto in patients with pulmonary TB.”
Prof. Andreas Diacon, Founder, Director & CEO at TASK: “At TASK we are excited to once again bring a novel, promising antibiotic to a tuberculosis patient for the very first time. BVL-GSK098 will, if successful, make an existing, low-cost and safe antibiotic much more potent and can be developed much quicker than a completely new substance. For ethionamide, the antibiotic boosted by BVL-GSK098, there is abundant safety data accumulated over many decades. BVL-GSK098 is particularly promising in tuberculosis meningitis where we urgently need more and better antibiotics.”
Dr. David Barros-Aguirre VP and Head of Global Health Medicines R&D Unit, Global Health R&D, GSK: “Today’s announcement marks an exciting moment for the TRIC-TB partnership and our efforts to improve the treatment options available for patients with tuberculosis. At GSK, we are committed to getting ahead of disease together, and positive results from this trial with compound BVL-GSK098 could validate a new concept to both overcome resistance and improve potency of an existing drug like ethionamide. This proof of concept study could bring us closer to new combination therapies to change the trajectory of the TB epidemic, that continues to have a devastating impact on many of the most vulnerable communities around the world.”
Dr. Marc Gitzinger, Chief Executive Officer and founder of BioVersys: “The global presence and recent increase in tuberculosis cases during the COVID-19 pandemic should serve as a reminder that we still urgently need new anti-TB drugs to help improve treatments and eradicate this devastating disease that affects 10 million people each year, and still kills 1.5 million annually. We are very grateful for the continued support of the European Union, and in particular the EDCTP, with their support we are testing BVL-GSK098 for the first time in a Phase 2a proof of concept trial, with the ultimate goal of developing a safer more efficacious therapy and shortening TB treatment times.”
Full PR available here