Item 8.01. Other Events.

On November 28, 2022, Nabriva Therapeutics plc (the "Company") announced positive topline results from its Phase 1 clinical trial that assessed the safety and pharmacokinetics ("PK") of oral and intravenous ("IV") XENLETA® (lefamulin) in adult patients with cystic fibrosis ("CF").

Data from the trial indicated that the PK of XENLETA in CF patients is consistent with that observed in previous single-dose healthy volunteer studies evaluating the approved oral and IV dosing for adults with community-acquired bacterial pneumonia ("CAPB"). In addition, XENLETA was well-tolerated and the adverse event profile in CF patients was consistent with that described across the Company's clinical program for XENLETA.

The Phase 1 trial is an open-label, randomized, single-dose, crossover study to assess the safety and pharmacokinetics of oral (600 mg) and IV (150 mg) XENLETA in adult patients with CF. The dosing utilized in the study is consistent with the U.S. Food and Drug Administration approved dosage for the treatment of adults with CABP.

© Edgar Online, source Glimpses