Ertapenem

GSK's phase 3 PIVOT-PO trial for tebipenem HBr was stopped early after an independent monitoring committee determined the oral carbapenem antibiotic was at least as effective as intravenous treatment for complicated urinary tract infections.

Bimekizumab gains EU approval and FDA acceptance for HS treatment based on Phase 3 BE HEARD trials, demonstrating significant improvements in skin pain.

Wockhardt's WCK 6777 (Ertapenem/Zidebactam) received FDA Fast Track designation for complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).

• Oral carbapenems like tebipenem HBr and sulopenem etzadroxil/probenecid aim to combat increasing gram-negative bacterial resistance, especially in complicated UTIs. • Tebipenem HBr initially showed noninferiority to intravenous ertapenem in a Phase III trial for cUTIs, but FDA concerns over the micro-ITT analysis halted its approval. • Sulopenem etzadroxil/probenecid demonstrated superiority to ciprofloxacin in uncomplicated UTIs caused by fluoroquinolone-resistant pathogens but failed to meet endpoints in cUTIs. • Despite the potential to reduce healthcare costs and offer an oral alternative to intravenous antibiotics, the future availability of these oral carbapenems remains uncertain due to regulatory setbacks.

• Iterum Therapeutics presented Phase 3 data for sulopenem in complicated and uncomplicated urinary tract infections (UTIs) at IDWeek 2020. • The SURE-1 trial demonstrated oral sulopenem's superiority to oral ciprofloxacin in treating uncomplicated UTIs caused by quinolone non-susceptible pathogens. • SURE-2 trial results for complicated UTIs involved IV sulopenem followed by oral sulopenem, compared to IV ertapenem followed by oral ciprofloxacin or amoxicillin-clavulanate. • Sulopenem, a novel penem anti-infective, is being developed in both oral and IV formulations to combat multi-drug resistant pathogens.