BioVersys’ second drug candidate enters clinical trials

BioVersys AG develops small molecules for multidrug-resistant bacterial infections. Having brought its first drug candidate BV100 into clinical trials last year in November, the company has kicked off another clinical phase of its second program BVL-GSK098 in collaboration with GSK to treat tuberculosis, one of the most formidable Global Health challenges. About 1.7 billion people, 23% of the world’s population, are estimated to have a latent TB infection, and are thus at risk of developing active TB disease during their lifetime, as currently estimated by World Health Organization (2018).

BVL-GSK098 is a novel compound potentiating and overcoming the resistance against ethionamide (Eto) or prothionamide (Pto) for the treatment of tuberculosis (TB). BVLGSK098 targets bacterial transcriptional regulators. The candidate has already undergone and completed GLP toxicology studies. The results demonstrated excellent in-vitro and in-vivo efficacy in animal models against multidrug-resistant TB (MDR-TB), including overcoming pre-existing resistance mechanisms in Mycobacterium tuberculosis by employing novel bioactivation pathways for Eto. 

BioVersys has now commenced the first global clinical trial of BVL-GSK098 to evaluate its safety and pharmacokinetics in healthy volunteers. The program is supported by the IMI2 AMR Accelerator from the EU (TRIC-TB Project), and it originates from BioVersys and its partners at the University of Lille and Pasteur Institute Lille, France.

“Although combinations for fighting resistance and (or) potentiating the action of a drug are well-known in the AMR field, this is 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,” said Sergio Lociuro, Chief Scientific Officer of BioVersys.

(Press release/RAN)