Nabriva Therapeutics Completes Patient Enrollment in Phase 1 Trial of XENLETA® (lefamulin) in Adult Patients with Cystic Fibrosis
- Topline Data Expected First Quarter 2023
Aug. 11, 2022 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced the completion of patient enrollment in its Phase 1 clinical trial to assess the safety and pharmacokinetics of oral and intravenous XENLETA® (lefamulin) in adult patients with cystic fibrosis (CF).
“We are happy to announce enrollment has been completed in this important study to evaluate the potential of XENLETA in the management of bacterial infections in patients with cystic fibrosis,” said Christine Guico-Pabia, M.D., MBA, MPH, Nabriva’s Chief Medical Officer. “XENLETA has the potential to provide a well-tolerated oral and intravenous anti-MRSA treatment option with a novel mechanism for this difficult to treat patient population.”
Dr. Guico-Pabia added, “With enrollment now complete, we expect to report topline data in the first quarter of 2023. We look forward to sharing the results of this study with the medical community. Thank you to the investigators and patients who participated in this important trial, as well as the Cystic Fibrosis Foundation for their support.”
About the Trial
The Phase 1 trial is an open-label, randomized, crossover study to assess the safety and pharmacokinetics following single doses of oral and intravenous XENLETA in adult patients with cystic fibrosis.
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.
XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. XENLETA’s binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Efficacy of XENLETA was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP. In these trials, XENLETA was compared with moxifloxacin and in one trial, moxifloxacin with and without linezolid. Patients who received XENLETA had similar rates of efficacy as those taking moxifloxacin alone or moxifloxacin plus linezolid. The most common adverse reactions associated with XENLETA included diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting. For more information, please visit www.XENLETA.com.
Nabriva Therapeutics plc