Nabriva Therapeutics to Present Lefamulin Data at ASM Microbe

Nabriva Therapeutics to Present Lefamulin Data at ASM Microbe

May 31, 2018 at 7:00 AM EDT
Potential of Lefamulin to Treat Patients with CABP Against Backdrop of Increasing Bacterial Resistance Presented on Eight Posters

DUBLIN, Ireland, May 31, 2018 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (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 will present data at the American Society for Microbiology (ASM) Microbe 2018 conference being held in Atlanta, Georgia from June 7-11, 2018.

These data are part of a growing body of evidence supporting lefamulin’s profile as a promising first-in-class pleuromutilin antibiotic treatment for key pathogens, including multidrug resistant strains, known to cause community-acquired bacterial pneumonia (CABP).

“CABP is a complex infection to treat, compounded by the fact that current therapies have limitations due to unwanted side effects and inadequate coverage given the mounting issue of antibiotic resistance. That is why we are moving with urgency to develop this new antibiotic class and making lefamulin available to patients and physicians around the world,” said Jennifer Schranz, M.D., chief medical officer of Nabriva Therapeutics. “We look forward to sharing with the scientific and medical community the full results from our first pivotal Phase 3 clinical study evaluating IV-to-oral lefamulin compared to a current gold-standard therapy. Additional data will further elucidate lefamulin’s mechanism of action, why it is thought to have a low propensity to develop resistance, and its potential to treat the pathogens most commonly associated with CABP, including multidrug resistant strains.”

Nabriva Therapeuticsrecently announced positive topline results from its second, pivotal Phase 3 clinical trial evaluating lefamulin compared to oral moxifloxacin in adult patients with moderate CABP. The data was consistent with findings from the company’s first pivotal Phase 3 clinical trial evaluating IV-to-oral lefamulin in patients with moderate to severe CABP compared to moxifloxacin with or without linezolid. Based on these data, the company remains on track to file a new drug application (NDA) for lefamulin with the U.S. Food and Drug Administration in the fourth quarter of this year and a marketing authorization application (MAA) with the European Medicines Agency a few months later.

Highlights of the data to be presented at ASM Microbe include:

Saturday, June 9 at 11:00-1:00 p.m. EDT

Poster #642
Presenter: Rodrigo E. Mendes, Ph.D.
Session: Pharmacological Studies of Antimicrobial agents Pre-NDA (Phase 2/3): New Agents between Phase 2 and FDA Approval
Title: Molecular Characterization of Resistance Mechanisms Associated with Pleuromutilins among Gram-Positive Clinical Isolates from the Worldwide Surveillance Studies for Lefamulin

Poster #643
Presenter: Susanne Paukner, Ph.D.
Session: Pharmacological Studies of Antimicrobial agents Pre-NDA (Phase 2/3): New Agents between Phase 2 and FDA Approval
Title: In Vitro Activity of Lefamulin against Bacterial Pathogens Commonly Causing Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and Bloodstream Infections (BSI): Global SENTRY Surveillance 2016

Poster #644
Presenter: Susanne Paukner, Ph.D.
Session: Pharmacological Studies of Antimicrobial agents Pre-NDA (Phase 2/3): New Agents between Phase 2 and FDA Approval
Title: In Vitro Activity of Lefamulin against Bacterial Pathogens Collected from Patients with Community-Acquired Respiratory Tract Infections (CARTI) - Global Sentry Surveillance 2016

Poster #557
Presenter: Wolfgang W. Wicha, M.Sc.
Session: Antimicrobial PK/PD & General Pharmacology in vivo Studies
Title: Tissue Distribution of [14C]-Lefamulin Into the Urogenital Tract in Rats

Poster #573
Presenter: Vikas Gupta, Pharm.D., BCPS

Session: Antimicrobial Stewardship including Quality of Care: Global Stewardship
Title: Correlation of High-Risk Antibiotic Use and Hospital-Associated C. difficile Infections:
Data from 195 US Hospitals

Poster #387
Presenter: Vikas Gupta, Pharm.D., BCPS
Session: Antimicrobial Stewardship including Quality of Care: Global Stewardship
Title: A Multicenter Evaluation of Pathogen Distribution in Patients Admitted with Microbiologically-Confirmed Community-Acquired Bacterial Pneumonia (CABP) in the US

Sunday, June 10 at 12:45-2:45 p.m. EDT

Poster #682
Presenter: David Mariano, PharmD
Session: Clinical Studies of Adult Infectious Diseases Respiratory Tract Infections
Title: Lefamulin is Non-Inferior to Moxifloxacin in Adults with Community-Acquired Bacterial Pneumonia (CABP): the Phase 3 Lefamulin Evaluation Against Pneumonia (LEAP 1) Study

Poster #683
Presenter: David Mariano, PharmD
Session: Clinical Studies of Adult Infectious Diseases Respiratory Tract Infections
Title: Lefamulin Demonstrates Favorable Safety and Tolerability in Adults with Community-Acquired Bacterial Pneumonia (CABP) in the Phase 3 Lefamulin Evaluation Against Pneumonia (LEAP 1) Study

The abstracts can be accessed through the ASM Microbe website. Following the meeting, the posters will be available on the Nabriva website.

About Nabriva Therapeutics plc
Nabriva Therapeutics is a biopharmaceutical company engaged in the research and development of new medicines 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. 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 CABP in more than a decade. Based on results from its two global, Phase 3 clinical trials, 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  favorable tolerability profile, with the results of its two global, pivotal trials showing a rate of treatment-emergent adverse events comparable to a fluoroquinolone antibiotic for CABP. Nabriva Therapeutics is evaluating the continued development of lefamulin for additional indications and is developing a formulation of lefamulin appropriate for pediatric use.

Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about the development of Nabriva Therapeutics’ product candidates, the clinical utility of lefamulin for CABP, Nabriva Therapeutics’ plans for filing of regulatory approvals, 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, Nabriva Therapeutics’ plans to enter into arrangements with external collaborators, 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: 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, whether results of Nabriva Therapeutics’ Phase 3 clinical trials of lefamulin are indicative of the clinical utility of lefamulin for CABP, 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 Therapeutics’ annual and quarterly reports 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 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 release.

CONTACTS:

FOR INVESTORS
Dave Garrett
Nabriva Therapeutics plc
david.garrett@nabriva.com
610-816-6657

FOR MEDIA
Benjamin Navon
W2O Group
bnavon@w2ogroup.com
617-337-4166

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Source: Nabriva Therapeutics US, Inc