XENLETA (Lefamulin) Treatment Results in a Rapid Time-to-Clinical Response in Hospitalized Patients with Community-Acquired Bacterial Pneumonia (CABP)

Results support Xenleta as an empiric, short-course monotherapy replacement for respiratory fluoroquinolones for treatment of CABP

DUBLIN, Ireland, May 05, 2020 (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 today that Open Forum Infectious Diseases, an official journal of the Infectious Diseases Society of America (IDSA), has published results from a post-hoc analysis of clinical data from patients who initiated treatment in the hospital from the pivotal Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Phase 3 clinical trials. The analyses indicate that lefamulin results in a rapid and similar time to clinical response, a proxy for hospital “discharge readiness,” compared to moxifloxacin.

“There is a clear need for new antibiotics for patients with CABP that result in similar real-world outcomes as fluoroquinolones without the safety concerns,” said Dr. Thomas Lodise, PharmD, PhD Albany College of Pharmacy and Health Sciences and lead author of the study. “Lefamulin has been shown to be non-inferior to moxifloxacin in the treatment of adults with CABP in two, multi-national clinical trials. The current analyses demonstrate that hospitalized adults with CABP treated with lefamulin achieve discharge readiness criteria rapidly. Given the safety concerns with the fluoroquinolones, these results add to the growing body of evidence that lefamulin should be considered as a potential monotherapy replacement for respiratory fluoroquinolones.”

In the post-hoc analysis, investigators examined pooled data of 926 inpatients from the LEAP trials; 468 patients were treated with lefamulin and 458 were treated with moxifloxacin. The analysis evaluated three outcomes among the study population: time to clinical response, time to clinical stability, and time to clinical improvement.

Of the 926 patients included, investigators were able to assess time to clinical response in 918, clinical stability in 925, and clinical improvement in 923. Analyses demonstrated that time to clinical response was nearly identical in both treatment groups, with a median (interquartile range) time from treatment initiation to clinical response of 4 (3-4) days for lefamulin and 4 (3-5) days for moxifloxacin. The median time from treatment initiation to clinical stability or clinical improvement was 3 (2-4) days in both the lefamulin and moxifloxacin groups.