—U.S. Food and Drug Administration (FDA)
At VenatoRx, we are pursuing novel chemical approaches to treat bacterial and viral infections. All of our investigational molecules were discovered internally.
Over many decades, bacteria have developed resistance to beta-lactam (BL) antibiotics by producing enzymes called beta-lactamases, which attack and destroy BL antibiotics. Today, over 70% of hospital based infections caused by gram-negative bacteria are associated with an antibiotic resistant organism.1 To overcome this resistance, BL antibiotics have been combined with protective beta-lactamase inhibitors (BLI). Unfortunately, existing BLIs are not sufficiently effective against the rapidly emerging extended spectrum beta-lactamases (ESBLs) and carbapenem-hydrolyzing beta-lactamases (carbapenemases). In addition, there are no approved BL based antibiotics that work against the metallo-beta-lactamase-producing superbugs carrying NDM or VIM.
VenatoRx’s most advanced development-stage product, VNRX-5133, is an injectable beta-lactamase inhibitor (BLI) that features selective and potent in vitro activity against both serine- and metallo-beta-lactamases, including ESBL, OXA, KPC, NDM, and VIM enzymes. VenatoRx believes that VNRX-5133, in a fixed combination with the fourth generation cephalosporin, cefepime, has the potential to provide a valuable broad-spectrum treatment option to meet unmet medical need in patients with infections due to carbapenem-resistant pathogens including carbapenem-resistant Enterobacteriaceae (CRE) and carbapenem-resistant Pseudomonas aeruginosa (CRPA), suspected polymicrobial infections caused by both gram-negative and gram-positive susceptible pathogens, and engineerable MDR bioterror pathogens such as Burkholderia spp. and Salmonella spp. Early clinical studies of cefepime/VNRX-5133 have been completed and VenatoRx intends to initiate Phase 3 pivotal trials during the second quarter 2019.
In addition to its BLI programs, VenatoRx is developing a radically new class of antibiotic. BL antibiotics, which include the highly successful penicillins, cephalosporins, monobactams, and carbapenems, all kill bacteria by blocking a key enzyme involved in cell wall synthesis: the penicillin binding protein (PBP). Our novel PBP inhibitors represent a new class of non-beta-lactam molecules that kill bacteria by this same mechanism. But because they are chemically distinct from the BLs, they are not susceptible to beta-lactamases. If successful, our PBP inhibitors have the potential to revolutionize treatment of MDR bacterial infections and set the resistance clock back by decades.
In addition to its antibacterial programs. VenatoRx has a broad pipeline of preclinical programs including novel antiviral agents targeting Hepatitis B Virus.