NEWS | BEAM Alliance


Nabriva Therapeutics Completes Patient Enrollment in Phase 1 Trial of XENLETA® (lefamulin) in Adult Patients with Cystic Fibrosis

August 11, 2022 at 7:01 AM EDT

– Topline Data Expected First Quarter 2023 –

DUBLIN, Ireland and FORT WASHINGTON, Pa., 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 -NCT05225805.

Er-Kim, added, “We are thrilled to partner with Nabriva to bring XENLETA to a region where there is a significant unmet need for patients with CABP. We feel privileged to work with Nabriva, who shares our passion in addressing patients’ unmet needs in serious infections.”

Full PR available here.