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Nabriva gains after announcing Phase 1 data for cystic fibrosis candidate

  • Ireland-based pharma Nabriva Therapeutics (NASDAQ:NBRV) rose ~15% on Monday morning after announcing results from a Phase 1 trial for its antibiotic Xenleta in adults with cystic fibrosis (CF).
  • The trial was designed to evaluate the safety and pharmacokinetics of oral (600 mg) and intravenous (150 mg) Xenleta in adults with CF.
  • Citing its topline results, Nabriva (NBRV) said that Xenleta pharmacokinetics were consistent with results in previous single-dose healthy volunteer studies, which evaluated the approved oral and IV dosing in adults with CABP.
  • Xenleta was also well tolerated indicating an adverse event profile consistent with its prior studies, the company added. The full results from the trial are expected in 1H 2023.
  • Also known as Lefamulin, Xenleta is already indicated in the U.S. as tablets and injections for treating adults with community-acquired bacterial pneumonia (CABP).
  • Read: Nabriva (NBRV) shares surged in July after announcing a distribution agreement with Er-Kim for the oral and intravenous Xenleta.