-Blinded interim analysis to confirm sample size expected in February 2017
VIENNA, Austria and KING OF PRUSSIA, Pa., Dec. 20, 2016 (GLOBE NEWSWIRE) -- Nabriva Therapeutics AG (NASDAQ: NBRV ), a clinical stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious infections, with a focus on the pleuromutilin class of antibiotics, today announced that it has achieved 60% of its enrollment target in the lefamulin evaluation against pneumonia (LEAP) 1 trial. LEAP 1 is a global, registrational Phase 3 clinical trial evaluating lefamulin in patients with moderate to severe community-acquired bacterial pneumonia (CABP). Based on current sample size estimates, the company expects to complete enrollment of 550 patients by the end of the second quarter of 2017.
“We have enrolled a sufficient number of patients to conduct an a priori , blinded interim analysis to confirm our sample size and power assumptions. Following data collection and analysis, an independent committee is expected to complete its review and make a recommendation in February 2017,” said Elyse Seltzer, M.D., chief medical officer of Nabriva.
“We are pleased with the progress of our lefamulin clinical development program for the treatment of CABP, a serious respiratory infection caused by bacteria that are becoming increasingly resistant to currently available therapies,” commented Colin Broom, M.D., chief executive officer of Nabriva. “Based on our current estimated patient randomization timelines for our two ongoing global Phase 3 CABP clinical trials, we continue to anticipate topline clinical data from both CABP trials in the second half of 2017.”
Lefamulin is a novel semi-synthetic pleuromutilin antibiotic with the potential to be the first-in-class available for systemic administration in humans. The company believes that lefamulin is the first antibiotic with a novel mechanism of action to have reached late-stage clinical development in more than a decade and is currently being evaluated in two global, registrational Phase 3 clinical trials in patients with moderate to severe CABP.
About the LEAP Program The LEAP program is comprised of two global, registrational Phase 3 clinical trials evaluating lefamulin for the treatment of CABP. LEAP 1 is a multi-center, randomized, controlled, double-blind trial comparing the safety and efficacy of lefamulin (IV/po) to moxifloxacin (IV/po) in moderate to severe CABP patients. If an investigator suspects MRSA at randomization, linezolid will be added to moxifloxacin, while matching placebo will be added to lefamulin. After three days of IV trial medication, investigators have the option to switch patients to oral therapy based on pre-defined criteria to complete treatment (a total of 7 days of therapy; for confirmed MRSA, a total of 10 days of therapy). The company is targeting the randomization of approximately 550 patients in this trial. LEAP 2 is a multi-center, randomized, controlled, double-blind trial comparing the safety and efficacy of 5 days of oral lefamulin to 7 days of oral moxifloxacin in patients with moderate CABP. The company is targeting the randomization of approximately 738 patients in this trial.
About Nabriva Therapeutics AG
Nabriva Therapeutics is a clinical stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious bacterial infections, with a focus on the pleuromutilin class of antibiotics. Nabriva's medicinal chemistry expertise has enabled targeted discovery of novel pleuromutilins, including both intravenous and oral formulations of its lead product candidate. Nabriva's lead product candidate, lefamulin, is a novel semi-synthetic pleuromutilin antibiotic with the potential to be the first-in-class available for systemic administration in humans. The company believes that lefamulin is the first antibiotic with a novel mechanism of action to have reached late-stage clinical development in more than a decade and is currently being evaluated in two global, registrational Phase 3 clinical trials in patients with moderate to severe CABP. Nabriva believes lefamulin is well positioned for use as a first-line empiric monotherapy for the treatment of moderate to severe CABP due to its novel mechanism of action, targeted spectrum of activity, resistance profile, achievement of substantial drug concentration in lung tissue and fluid, oral and IV formulations and a favorable tolerability profile. Nabriva also intends to further pursue the development of lefamulin for additional indications, including the treatment of acute bacterial skin and skin structure infections (ABSSSI), and is developing a formulation of lefamulin appropriate for pediatric use.
Nabriva owns exclusive, worldwide rights to lefamulin, which is protected by composition of matter patents issued in the United States, Europe and Japan.
Forward Looking Statements
Any statements in this press release about future expectations, plans and prospects for Nabriva, including but not limited to statements about the development of Nabriva’s product candidates, such as plans for the design, conduct and timelines of Phase 3 clinical trials of lefamulin for CABP, the clinical utility of lefamulin for CABP and Nabriva’s plans for filing of regulatory approvals and efforts to bring lefamulin to market, the development of lefamulin for additional indications, the development of additional formulations of lefamulin, plans to pursue research and development of other product candidates, 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: 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 trials 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 product candidates including lefamulin for use as a first-line empiric monotherapy for the treatment of moderate to severe CABP, the sufficiency of cash resources and need for additional financing and such other important factors as are set forth under the caption "Risk Factors" in Nabriva’s annual report on Form 20-F and its prospectus supplement dated November 29, 2016 filed with the United States Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva’s views as of the date of this release. Nabriva anticipates that subsequent events and developments will cause its views to change. However, while Nabriva 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’s views as of any date subsequent to the date of this release.
CONTACT: INVESTOR RELATIONS Will Sargent Nabriva Therapeutics AG William.Sargent@nabriva.com MEDIA Katie Engleman Pure Communications, Inc. Katie@purecommunicationsinc.com
