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Nabriva Therapeutics Announces First Patient Enrolled in Phase 1 Trial of XENLETA® (lefamulin) in Adult Patients with Cystic Fibrosis

April 11, 2022 at 4:05 PM EDT

DUBLIN, Ireland and FORT WASHINGTON, Pa., April 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 that the first patient was enrolled in a 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 excited to commence enrollment 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. “The management of S. aureus infection in cystic fibrosis patients is challenging and data from the 2020 CF Foundation Patient Registry Report shows that S. aureus remains the most common respiratory pathogen identified in patients with CF1. Importantly, the presence of methicillin-resistant S. aureus (MRSA), in a respiratory tract culture negatively impacts the median survival time in CF patients, with an observed reduction of 6.2 years as compared to CF patients with a respiratory culture that is negative for MRSA2,3.”

Dr. Guico-Pabia added, “To treat bacterial infections in patients with CF, clinicians have had to rely upon agents that have not been demonstrated to be reliably effective for the treatment of MRSA, require intravenous administration, or have significant safety and tolerability issues limiting their clinical utility. 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. We look forward to sharing the results of this study with the medical community.”

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