BVL-GSK098 is being developed for the treatment of multidrug-resistant Tubercolosis infections. BioVersys has reached another major milestone by moving a second program into clinical development with the start of Phase 1 testing for BVL-GSK098 in healthy volunteers.
BioVersys AG, a privately owned, multi-asset Swiss pharmaceutical company focused on developing small molecules for multidrug-resistant bacterial infections with applications in Anti-Microbial Resistance (AMR) and targeted microbiome modulation, today announced that the first healthy volunteers have received BVL-GSK098 in a Phase 1 clinical trial designed to evaluate the safety, tolerability, and pharmacokinetics of BVL-GSK098 in healthy human volunteers through Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies.
Dr. Sergio Lociuro, Chief Scientific Officer of BioVersys: “We are very excited to be testing BVL-GSK098 in a Phase 1 clinical trial, to evaluate its safety and pharmacokinetics in healthy volunteers. Although combinations for fighting resistance and/or potentiating the action of a drug are well known in the AMR field (e.g. beta-lactams/beta-lactamase inhibitors), thisis the first time that such an approach is applied in the TB field. Indeed, BVL-GSK098 combined with Eto or Pto offers the potential of increasing the potency of these drugs at significantly better tolerated low doses, while making them more bactericidal, faster-acting and active against Eto-Pto- and INH-resistant strains.”
Dr. David Barros-Aguirre, VP and Head of Global Health Pharma Research Unit, Global Health Pharma R&D, GSK: “GSK is committed to the discovery of novel treatments for tuberculosis including the drug-resistant forms of Mycobacterium tuberculosis. Entering clinical trials is an important milestone in our successful collaboration with BioVersys as we develop BVL-GSK098 within the IMI-2 TRIC-TB program, towards a potential treatment to optimize the beneficial effects of ethionamide.”
Dr. Marc Gitzinger, CEO and co-founder of BioVersys: “More than 1.5 million people die every year from Tuberculosis through a lack of efficacious treatments and access to medicines. In the midst of the current Covid-19 pandemic, this death toll is expected to rise significantly. At BioVersys we remain committed to developing innovative and life-saving treatments for patients suffering from drug-resistant infections, and the combination of BVL-GSK098 and Eto (or Pto) has the potential to improve patient outcomes, reduce treatment times, and even replace INH in first-line TB therapy.”
Dr. Seng Chin Mah, Chairman of BioVersys: “The BioVersys team has achieved yet another significant milestone by progressing a second program, BVL-GSK098, a novel treatment for highly resistant TB infections, into clinical development. This takes place within weeks of BV100 entering clinical development. We have now met all our immediate term goals for clinical development and look forward to executing on the next phase of our strategic plan as a significant innovator of urgently needed medicines in the AMR field.
The objective is to progress clinical candidates that potentiate the efficacy of and reverse the resistance to the anti-tubercular pro-drug ethionamide (Eto). The World Health Organization (WHO) considers Eto a crucial pillar of TB treatment, especially against MDR (multidrug-resistant) and XDR (extensively drug-resistant) strains. Our “booster” molecules act on novel bacterial transcription regulator targets, resulting in an increase of Eto efficacy by at least three-fold in vivo. This allows the use of lower efficacious doses of Eto in human anti-tuberculosis treatments and with a resultant reduction in dose dependent adverse effects in TB patients. Furthermore, data shows that the small molecules overcome pre-existing resistance mechanisms against Eto in Mycobacterium tuberculosis by employing novel bioactivation pathways for Eto, thus increasing the level of bioactivation. TRIC-TB has the potential to deliver a novel, fast acting TB agent potentially replacing Isoniazid as first line TB therapy.