Nabriva to Present Data at the CHEST Annual Meeting Demonstrating the Safety and Efficacy of Newly FDA-Approved XENLETA (lefamulin) for the Treatment of Community-Acquired Bacterial Pneumonia (CABP)
“The clinical community desperately needs new classes of antibiotics with different mechanisms of action that have targeted, potent antimicrobial activity and improved safety and tolerability over existing therapies,” said
Results from the pivotal Lefamulin Evaluation Against Pneumonia (LEAP) 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 (LEAP) 1 And LEAP 2 Double-Blind Noninferiority Phase 3 Clinical Trials
Date and Time:
Poster #: E1006
This pooled efficacy assessment of the LEAP 1 and 2 studies reported the early clinical response (ECR) at 96 ± 24 hours after first dose of study drug among 1289 randomized patients, and the investigator assessment of clinical response (IACR) at test-of-cure (TOC): five to 10 days after last dose of study drug in the modified intent-to-treat population – those receiving ≥1 dose of study drug and in the clinically evaluable populations. In addition to efficacy overall, analyses stratified by Pneumonia Outcomes Research Team (PORT) 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 (LEAP) 1 and LEAP 2 Double-Blind Noninferiority Phase 3 Clinical Trials
Date and Time:
Poster #: E1053
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 (LEAP) 1 and LEAP 2 Double Blind Noninferiority Phase 3 Clinical Trials
Date and Time:
Poster #: E1142
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 (five to seven days) with lefamulin for atypical pathogens resulted in high ECR responder and IACR success rates and was generally well tolerated in comparison to moxifloxacin.
Community-acquired bacterial pneumonia (CABP) is a lung infection and the most common type of pneumonia. In CABP, infection occurs outside of hospitals or other health care facilities. The most common cause of CABP in
XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the
INDICATION AND IMPORTANT SAFETY INFORMATION
XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
IMPORTANT SAFETY INFORMATION
XENLETA is contraindicated in patients with known hypersensitivity to XENLETA or pleuromutilins.
XENLETA tablets are contraindicated for use with CYP3A4 substrates that prolong the QT interval.
WARNINGS AND PRECAUTIONS
XENLETA has the potential to prolong the QT interval. Avoid XENLETA in patients with known QT prolongation, ventricular arrhythmias, and patients receiving drugs that may prolong the QT interval.
Based on animal studies, XENLETA may cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.
Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including XENLETA, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.
The most common adverse reactions (≥2%) for (a) XENLETA Injection are administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, and headache and (b) XENLETA Tablets are diarrhea, nausea, vomiting, and hepatic enzyme elevation.
USE IN SPECIFIC POPULATIONS
In patients with severe hepatic impairment, reduce the dosage of XENLETA Injection to 150 mg infused over 60 minutes every 24 hours. XENLETA Tablets are not recommended in patients with moderate or severe hepatic impairment due to insufficient information to provide dosing recommendations.
Avoid XENLETA Injection and Tablets with concomitant strong or moderate CYP3A or P-gp inducers. Monitor for reduced efficacy of XENLETA.
Avoid XENLETA Tablets with strong CYP3A or P-gp inhibitors.
Monitor for adverse reactions of sensitive CYP3A substrates administered with XENLETA Tablets.
XENLETA has not been studied in pregnant women. Verify pregnancy status in females prior to initiating XENLETA and advise females to use contraception during treatment and for 2 days after the final dose. Lactating women should pump and discard milk for the duration of treatment with XENLETA and for 2 days after the final dose.
To report SUSPECTED ADVERSE REACTIONS, or administration during pregnancy, contact
Please see Full Prescribing Information for XENLETA.
Any statements in this press release about future expectations, plans and prospects for
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Source: Nabriva Therapeutics US, Inc