October 13, 2020 at 7:00 AM EDT
— Findings underscore potential of XENLETA as a first-in-class pleuromutilin antibiotic for the IV and oral treatment of CABP in adults, including older patients with comorbidities who are at risk of poor outcomes —
— Pooled analysis of data by age group from pivotal LEAP 1 and LEAP 2 Phase 3 clinical trials to be presented at CHEST Annual Meeting 2020 —
DUBLIN, Ireland, Oct. 13, 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, today announced that 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. Results of the pooled analysis from the pivotal Phase 3 clinical trials of XENLETA will be presented at the virtual CHEST Annual Meeting, October 18-21, 2020.
“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. Full results of the pooled analyses presented at the virtual CHEST Annual Meeting can be found here.
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