Nabriva Therapeutics has announced positive topline results from a phase 1 clinical trial assessing the safety and pharmacokinetics of lefamulin (Xenleta®) in adult patients with cystic fibrosis (CF).

In a press release, Christine Guico-Pabia, MD, MBA, MPH, chief medical officer of Nabriva Therapeutics, was thrilled to share the new data. “The data indicate that the pharmacokinetics 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 (CABP). In addition, Xenleta was well-tolerated and the adverse event profile in CF patients was consistent with that described across our clinical program,” she said.

Adult patients with CF enrolled in the open-label, randomized, single-dose, crossover phase 1 trial received either oral (600 mg) or IV (150 mg) lefamulin. The dosage was selected according to the regimen currently approved by the US Food and Drug Administration for the treatment of adults with CABP.

“Xenleta has been demonstrated to be a potent anti-staphylococcal antibiotic in in vitro and clinical studies, including against methicillin-resistant S. aureus [Staphylococcus aureus],” Dr. Guico-Pabia further explained. “There are limited treatment options for the management of bacterial exacerbations in CF patients caused by S. aureus and the results of this study support the potential utility of Xenleta in this difficult to treat patient population. We would like to thank the study participants, investigators, and the Cystic Fibrosis Foundation for their support of this important study and look forward to sharing the complete results with the medical community in the first half of 2023.”

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Lefamulin is pleuromutilin antibacterial indicated for the treatment of adults with CABP caused by Streptococcus pneumoniae, S. aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.


Nabriva Therapeutics announces positive topline results from phase 1 trial of XENLETA® (lefamulin) in adult patients with cystic fibrosis. News release. Nabriva Therapeutics US, Inc.; November 28, 2022.