Ertapenem

Spero Therapeutics Announces Positive Topline Results from its Phase 3 ADAPT-PO Clinical Trial of Oral Tebipenem HBr in Complicated Urinary Tract Infection and Acute Pyelonephritis

Retrieved on: 
Tuesday, September 8, 2020
Carbapenem antibiotics, Chemical compounds, Organic compounds, Pyrrolidines, Prodrugs, Tebipenem, Ertapenem

Topline data from the trial demonstrate that oral tebipenem HBr was statistically non-inferior to intravenous (IV) ertapenem in the treatment of patients with cUTI and patients with AP.

Key Points: 
  • Topline data from the trial demonstrate that oral tebipenem HBr was statistically non-inferior to intravenous (IV) ertapenem in the treatment of patients with cUTI and patients with AP.
  • The global Phase 3 ADAPT-PO clinical trial evaluated the safety and efficacy of oral tebipenem HBr versus IV ertapenem for the treatment of adults with cUTI or AP.
  • Serious TEAEs were infrequent (1.3% for tebipenem HBr vs. 1.7% for ertapenem) and no deaths were reported in the trial.
  • We are thrilled to announce positive ADAPT-PO results that we believe demonstrate the value of tebipenem HBr for healthcare providers, payers and patients.

Successful USFDA inspection of Asymchem Fuxin 1 carbapenem manufacturing facility

Retrieved on: 
Friday, June 1, 2018
Carbapenem antibiotics, Chemistry, Pyrrolidines, Organic chemistry, Carbapenem, Fuxin, Tebipenem, Meropenem, Ertapenem

TIANJIN, China, June 1, 2018 /PRNewswire/ --Asymchem, a leading custom manufacturer of Intermediates and API's for the life sciences industry, today announced that its Fuxin 1 site, a dedicated carbapenem manufacturing facility, successfully passed the U.S. Food and Drug Administration (USFDA) general GMP reinspection conducted between March 12-15, 2018.

Key Points: 
  • TIANJIN, China, June 1, 2018 /PRNewswire/ --Asymchem, a leading custom manufacturer of Intermediates and API's for the life sciences industry, today announced that its Fuxin 1 site, a dedicated carbapenem manufacturing facility, successfully passed the U.S. Food and Drug Administration (USFDA) general GMP reinspection conducted between March 12-15, 2018.
  • Previous FDA inspections of Fuxin 1 took place in 2011 and 2014.
  • Asymchem's Fuxin, P. R. China site produces the carbapenem intermediate Enol Phosphate (ertapenem, meropenem and tebipenem), for which Asymchem holds an active Drug Master File, as well as other carbapenem intermediates.
  • Asymchem will expand its carbapenem production capacity with the opening of Dunhua 2 site in April 2019.