XENLETA Demonstrates High Efficacy in Community-Acquired Bacterial Pneumonia

Nabriva Therapeutics announced in a post-hoc analysis of the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 trials by age, XENLETA™ (lefamulin) demonstrated consistently high efficacy and similar safety and tolerability profiles across all patient groups, including adults over 65 years of age who are at higher risk of morbidity and mortality from CABP. CABP is the most common cause of infectious death in U.S. adults age 65 and older.

“People of advanced age are especially at risk for developing CABP as a result of a weakened immune system and age-related comorbidities that increases the chances of hospitalization and CABP-related complications leading to functional impairment and/or mortality,” said Jennifer Schranz, MD, Chief Medical Officer of Nabriva. “Our post-hoc analysis highlights that XENLETA provides a safe and effective empiric monotherapy alternative to fluoroquinolones for treatment of CABP in patients with advanced age and comorbidities.”

In this pooled analysis of 1289 patients from LEAP 1 and LEAP 2 by age group, including adults ages 18-64, 65-74, 75-84, and 85 and older, 40 percent of the overall pooled patient population was over 65 years of age. Compared to younger patients, patients 65 years of age and older had higher pneumonia severity scores and were more likely to have renal impairment, cardiac disease, hypertension, diabetes or asthma/COPD. The analysis showed that early clinical response (ECR) and investigator assessment of clinical response (IACR) at the Test of Cure (TOC) for XENLETA were high (approximately 90%) and similar to that of moxifloxacin, a current standard of care fluoroquinolone for CABP, for all age groups. The adverse event profile and study drug discontinuation rates were similar across all age groups.

XENLETA is a first-in-class systemic pleuromutilin antibiotic with a unique mechanism of action that attacks the difficult-to-treat pathogens in CABP and addresses the challenges of antibiotic resistance. It is approved by the FDA for the IV and oral treatment of CABP in adults.

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.

XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for 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 include diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting.