The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Pfizer Inc.’s Emblaveo (aztreonam-avibactam), an antibiotic combination that would offer a new option to patients with serious bacterial infections caused by multidrug-resistant gram-negative bacteria.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Pfizer Inc.’s Emblaveo (aztreonam-avibactam), an antibiotic combination that would offer a new option to patients with serious bacterial infections caused by multidrug-resistant gram-negative bacteria. If approved, Emblaveo would be among the first beta-lactam/beta-lactamase inhibitor combos cleared for use in Europe.
Researchers from Contrafect Corp. have reported on the bactericidal activity of CF-370, a novel engineered lysin with broad-spectrum activity against gram-negative organisms, which are usually more resistant to antibacterial agents than gram-positive bacteria.
The good news is that the U.S. FDA’s complete response letter (CRL) for Venatorx Pharmaceuticals Inc.’s intravenous antibiotic combination, cefepime-taniborbactam, in complicated urinary tract infections (cUTIs) requested no additional clinical testing. The bad news is the inevitable delay for a drug Venatorx and partner Melinta Therapeutics Inc. are aiming to position as a much-needed option for the fight against drug-resistant gram-negative infections.
Basilea Pharmaceutica Ltd. has entered into an asset purchase agreement with Spexis AG for a preclinical program of antibiotics from a novel class, targeting gram-negative bacteria, including multidrug-resistant strains.
Merck Sharp & Dohme LLC has divulged compounds acting as lipid A export ATP-binding/permease protein (MsbA) inhibitors reported to be useful for the treatment of gram-negative (multidrug-resistant) bacterial infections.
Glox Therapeutics Ltd. has raised £4.3 million (US$5.37 million) in seed funding to develop targeted therapeutics against antibiotic-resistant gram-negative bacteria. The company was founded earlier this year as a spin-out from the Universities of Glasgow and Oxford.
Benzamide compounds acting as UDP-2,3-diacylglucosamine hydrolase (LpxH) (bacterial) inhibitors have been reported in an F. Hoffmann-La Roche Ltd. patent to be useful for the treatment of gram-negative bacterial infections, particularly Klebsiella pneumoniae and Escherichia coli infections.
A different class of antibiotics could ease the increasing resistance triggered by some gram-negative bacteria. LpxC inhibitors are not new, but all attempts to develop them have failed due to cardiovascular toxicity or ineffectiveness. A modification of the structure of these compounds may have solved the problem. Duke University scientists demonstrated the preclinical safety and efficacy of an LpxC inhibitor candidate against a wide selection of these pathogens.
Merck & Co. Inc. has reported the development of a novel monobactam for use in combination with its class A/C β-lactamase inhibitor (BIL) relebactam (MK-7655) in order to achieve the broadest activity against multidrug-resistant (MDR) gram-negative pathogens that express a variety of β-lactamases. The in vitro efficacy of the combination of the monobactam – MSD-045934942 – against a panel of MDR and non-MDR gram-negative bacteria was evaluated using in vitro broth microdilution testing.
