Nabriva Therapeutics Announces Positive Topline Results from Phase 1 Trial of XENLETA® (lefamulin) in Adult Patients with Cystic Fibrosis
- PK Data and Safety Profile Consistent with Previous Studies in Healthy Subjects
- Results Support Potential Utility of Lefamulin in Patients with Cystic Fibrosis
Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced positive topline results from their 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).
“We are excited to share positive topline results from this important study of XENLETA in patients with CF,” said Christine Guico-Pabia, M.D., MBA, MPH, Nabriva’s Chief Medical Officer. “The data indicate 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 (CABP). In addition, XENLETA was well-tolerated and the adverse event profile in CF patients was consistent with that described across our clinical program.
Dr. Guico-Pabia added, “XENLETA has been demonstrated to be a potent anti-staphylococcal antibiotic in in vitro and clinical studies, including against methicillin-resistant S. aureus (MRSA). 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.”
About the Trial
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 cystic fibrosis. The dosing utilized in this study is consistent with the FDA approved dosage for the treatment of adults with CABP.
More information can be found at ClinicalTrials.gov -NCT05225805.
About Nabriva Therapeutics plc
Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA® (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis. Nabriva entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO® (tedizolid phosphate) in the United States and certain of its territories.
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Nabriva Therapeutics plc
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