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 following a blinded interim analysis, an independent committee recommended no sample size adjustment for the lefamulin evaluation against pneumonia (LEAP) 1 Phase 3 clinical trial. This was a prospectively defined, blinded interim analysis to confirm the sample size and power assumptions that was planned to occur after the trial achieved 60% of its enrollment target. The company expects to complete LEAP 1 enrollment of approximately 550 patients with moderate to severe community-acquired bacterial pneumonia (CABP) in the second quarter of 2017 and announce topline LEAP 1 data by the end of the third quarter of 2017.
“We are pleased that the committee confirmed that the original sample size of approximately 550 patients in LEAP 1 is sufficient to evaluate efficacy as assessed by the FDA primary endpoint of Early Clinical Response,” said Elyse Seltzer, M.D., chief medical officer of Nabriva Therapeutics. “Following final data collection and analysis, we expect to announce LEAP 1 topline efficacy and safety data by the end of the third quarter of 2017.”
LEAP 1 is a Phase 3 multicenter, randomized, controlled, double-blind, global, registrational clinical trial comparing the safety and efficacy of lefamulin (IV/po) to moxifloxacin (IV/po) in patients with moderate to severe CABP. If, at randomization, an investigator suspects MRSA as the causative bacteria, 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, based on pre-defined criteria, to switch patients to oral therapy to complete treatment (a total of 7 days of therapy; for confirmed MRSA, a total of 10 days of therapy).
“CABP is a serious respiratory infection in need of novel antibiotics, as both antimicrobial stewardship and increasing bacterial resistance continue to influence antibiotic choice, and bacterial resistance continues to render existing antibiotics less effective,” commented Colin Broom, M.D., chief executive officer of Nabriva Therapeutics. “We are encouraged with the progress of our lefamulin clinical development program for the treatment of patients with this serious condition. This year has the potential to be transformational for Nabriva Therapeutics, as we anticipate topline clinical data from both of our global, registrational CABP Phase 3 trials in the second half of 2017.”
Lefamulin is a semi-synthetic pleuromutilin antibiotic with the potential to be the first-in-class pleuromutilin 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 for CABP in more than a decade.
About Nabriva Therapeutics AG
Nabriva Therapeutics is a clinical stage biopharmaceutical company engaged in the research and development of novel anti-infectives to treat serious bacterial infections, with a focus on the pleuromutilin class of antibiotics. Nabriva Therapeutics’ medicinal chemistry expertise has enabled targeted discovery of novel pleuromutilins, including both intravenous and oral formulations of its lead product candidate. Nabriva Therapeutics’ 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. Lefamulin is currently being evaluated in two global, registrational Phase 3 clinical trials in patients with moderate to severe CABP. Nabriva Therapeutics 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 Therapeutics intends to further pursue 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 Therapeutics 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.