Poster sessions to highlight pooled results from the pivotal LEAP 1 and LEAP 2 Phase 3 clinical trials
DUBLIN, Ireland, Oct. 15, 2019 (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, announced today that it will present data on the pooled results from completed Phase 3 trials of XENLETA™ (lefamulin) at the CHEST Annual Meeting 2019, to be held October 19-23 in New Orleans. XENLETA is a first-in-class pleuromutilin antibiotic for the intravenous (IV) and oral treatment of community-acquired bacterial pneumonia (CABP) in adults and is now commercially available in the United States.
“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 Jennifer Schranz, M.D., Chief Medical Officer of Nabriva Therapeutics. “With the arrival of the flu season and the increased risk of respiratory infections during the winter months, XENLETA’s availability is more important than ever. We look forward to informing the CHEST professional community about the benefits and safety profile of this new antibiotic as a short-course, empiric monotherapeutic treatment option for adults with CABP.”
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
Presenter: Christian E. Sandrock, M.D.
Date and Time: Monday, October 21, 2:30 p.m. – 3:15 p.m. CT
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
Presenter: Christian E. Sandrock, M.D.
Date and Time: Tuesday, October 22, 1:00 p.m. – 2:00 p.m. CT
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
Presenter: David Mariano
Date and Time: Tuesday, October 22, 1:00 p.m. – 2:00 p.m. CT
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 the United States is Streptococcus pneumoniae. This type of pneumonia can occur on its own following the flu and can cause shortness of breath, fever and cough. It is estimated that there are between five to six million cases of CABP in the U.S. annually.
About Nabriva Therapeutics plc
Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA™ (lefamulin), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis. For more information, please visit www.nabriva.com.
XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic 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.
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 Nabriva Therapeutics US, Inc. at 1-855-5NABRIVA or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see Full Prescribing Information for XENLETA.
Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about launch and commercialization of XENLETA for the treatment of CABP, marketing exclusivity and patent protection for XENLETA, the development of CONTEPO for cUTI, the clinical utility of XENLETA for CABP and of CONTEPO for cUTI, plans for and timing of the review of regulatory filings for CONTEPO, efforts to bring XENLETA and CONTEPO to market, the market opportunity for and the potential market acceptance of XENLETA for CABP and CONTEPO for cUTI, the development of XENLETA and CONTEPO for additional indications, the development of additional formulations of XENLETA and CONTEPO, plans to pursue research and development of other product candidates, the sufficiency of Nabriva Therapeutics’ existing cash resources and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: Nabriva Therapeutics’ ability to successfully implement its commercialization plans for XENLETA and whether market demand for XENLETA is consistent with its expectations, Nabriva Therapeutics’ ability to build and maintain a sales force and prepare for commercial launch of XENLETA on the timeline expected, or at all, the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or studies in different disease indications will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of CONTEPO for the treatment of cUTI or of XENLETA for the treatment of CABP, the ability to retain and hire key personnel, the sufficiency of cash resources and need for additional financing and such other important factors as are set forth in Nabriva Therapeutics’ annual and quarterly reports and other filings on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics’ views as of the date of this press release. Nabriva Therapeutics anticipates that subsequent events and developments will cause its views to change. However, while Nabriva Therapeutics may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva Therapeutics’ views as of any date subsequent to the date of this press release.
Nabriva Therapeutics plc
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