Nabriva Therapeutics PLC (NBRVF)

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XENLETA® (Lefamulin) Treatment Results in a Rapid Time-to-Clinical Response in Hospitalized Patients with Community-Acquired...
May 05 2020 - 07:00AM
GlobeNewswire Inc.

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.

Given the association between time to clinical response and readiness for hospital discharge in patients with CABP, the findings support the potential of lefamulin as an effective IV and oral short-course, monotherapy for CABP that may enable early discharge.

“In the treatment of hospitalized patients with CABP, length of stay is the primary driver of the cost of care,” said Dr. Lodise. “Innovative antibiotics, such as lefamulin, that are safe and efficacious, and are shown to result in a rapid time to clinical response are critical to providing the most cost-effective and highest quality care to our patients.”

XENLETA™ is a first-in-class pleuromutilin antibiotic approved by the U.S. Food and Drug Administration (FDA) for the treatment of community-acquired bacterial pneumonia. It is available in IV and oral formulations enabling initiation of treatment in the hospital, transitioning to outpatient setting or initiating treatment in the community. XENLETA has a novel mechanism of action that targets a binding site on bacteria that is different from existing antibiotics which has been shown to result in no cross resistance to other antibiotic classes commonly prescribed for CABP and a low potential for the development of resistance.

Full results of the post-hoc analysis of LEAP trials data is included in the paper titled: Post Hoc Assessment of Time to Clinical Response Among Adults Hospitalized with Community-Acquired Bacterial Pneumonia Who Received Either Lefamulin or Moxifloxacin in Two Phase III Randomized, Double-Blind, Double-Dummy Clinical Trials, published in Open Forum Infectious Diseases, April 24, 2020.

About CABP

Pneumonia is an infection of the lung that can be serious and fatal, especially among older adult patients with comorbidities. There are approximately five million cases of pneumonia in the U.S. each year, and pneumonia is the fifth leading cause of hospitalization and one of the leading causes of infection-related death. Streptococcus pneumoniae is the most common cause of bacterial pneumonia in the U.S. According to recent data from the SENTRY Antimicrobial Surveillance Program, in the U.S., approximately 30 to 60 percent of S. pneumoniae, depending on region, are macrolide resistant. In addition to macrolides, fluoroquinolones are another common treatment option for CABP. This broad-spectrum class is an effective option; however, fluoroquinolones carry boxed warnings for several significant safety concerns.