Nabriva Therapeutics to present data from Phase 3 trials of XENLETA
Nabriva Therapeutics announced that it will present data on the pooled results from completed Phase 3 trials of XENLETA at the CHEST Annual Meeting 2019. XENLETA is a pleuromutilin antibiotic for the intravenous and oral treatment of community-acquired bacterial pneumonia in adults and is now commercially available in the United States. Results from the pivotal Lefamulin Evaluation Against Pneumonia 1 and LEAP 2 Phase 3 clinical trials will be featured in three e-poster presentations during a moderated grand-rounds session at the CHEST meeting. These studies demonstrated that XENLETA is a well-tolerated, new IV and/or oral antimicrobial monotherapy for the empiric treatment of adults with CABP and a clinical alternative to moxifloxacin, a current standard of care fluoroquinolone. The data also showed that early clinical response rates of XENLETA, as well as health-related quality of life improvements, were high and similar to that of moxifloxacin in at-risk groups, including patients age 65 years or greater, who are at the highest risk of morbidity and mortality. Details for the upcoming presentations are as follows: Title: Efficacy of Lefamulin Versus Moxifloxacin in Adults with Community-Acquired Bacterial Pneumonia: Results of the Lefamulin Evaluation Against Pneumonia 1 And LEAP 2 Double-Blind Noninferiority Phase 3 Clinical Trials. This pooled efficacy assessment of the LEAP 1 and 2 studies reported the early clinical response at 96 +/- 24 hours after first dose of study drug among 1289 randomized patients, and the investigator assessment of clinical response at test-of-cure: five to 10 days after last dose of study drug in the modified intent-to-treat population - those receiving greater than or equal to1 dose of study drug and in the clinically evaluable populations. In addition to efficacy overall, analyses stratified by Pneumonia Outcomes Research Team Risk Class, from both pooled and individual trials, were presented. CABP patients treated with lefamulin demonstrated high response rates for ECR and IACR and was noninferior to moxifloxacin. Response rates with lefamulin IV and/or oral therapy remained high across the indices of severity. Title: Safety and Tolerability of Lefamulin Versus Moxifloxacin in Adults with Community-Acquired Bacterial Pneumonia: Results of the Lefamulin Evaluation Against Pneumonia 1 and LEAP 2 Double-Blind Noninferiority Phase 3 Clinical Trials. The objective of this pooled safety assessment of the LEAP 1 and 2 studies was to identify treatment-emergent adverse events among patient groups treated with lefamulin versus moxifloxacin. Pooled data from the LEAP 1 and LEAP showed similar safety and tolerability profiles for lefamulin and moxifloxacin. Title: Efficacy and Safety of Lefamulin Versus Moxifloxacin for Atypical Respiratory Pathogens in Adults with Community-Acquired Bacterial Pneumonia: Pooled Results from the Lefamulin Evaluation Against Pneumonia 1 and LEAP 2 Double Blind Noninferiority Phase 3 Clinical Trials. This analysis was to determine the safety and efficacy of lefamulin versus moxifloxacin in patients with atypical respiratory pathogens including Mycoplasma pneumoniae, Legionella pneumophila, and Chlamydophila pneumoniae. In the pooled patient population, short-course therapy with lefamulin for atypical pathogens resulted in high ECR responder and IACR success rates and was generally well tolerated in comparison to moxifloxacin.