Nabriva Therapeutics Announces Completion of Enrollment in LEAP 2, a Phase 3 Clinical Trial Evaluating Oral Lefamulin for the Treatment of Community-Acquired Bacterial Pneumonia in Adults
“The lack of truly novel classes of antibiotics in the pipeline is one of the single greatest threats to public health of our lifetime. Our mission is to bring a desperately needed new class of antibiotics to patients and physicians, and today, we are one step closer to achieving this goal,” said Dr.
In preclinical studies, lefamulin has demonstrated a targeted spectrum of activity against the pathogens that most commonly cause CABP, including multi-drug resistant strains. Due to its unique mechanism of action, cross-resistance between lefamulin and other antibacterial agents commonly used to treat CABP is rare, and lefamulin has shown a low propensity for drug resistance to develop. Furthermore, the availability of both oral and IV formulations and favorable tolerability profile make it a potential candidate as a first-line empiric monotherapy for In-Hospital, Transition of Care and Community treatment of CABP.
About LEAP 2 Clinical Trial Design
LEAP 2, is a multi-center, randomized, controlled, double-blind, global study comparing oral lefamulin to moxifloxacin, a fluroquinolone antibiotic. LEAP 2 is designed to evaluate the efficacy and safety of oral lefamulin compared to oral moxifloxacin in patients with moderate CABP. All patients enrolled in LEAP 2 have a PORT class severity of 2 to 4 on a scale of 1 to 5, which corresponds to moderate disease.
CABP is a leading cause of infectious deaths and hospitalization in
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 Nabriva’s ongoing Phase 3 clinical trial 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 market opportunity for and the potential market acceptance of lefamulin for CABP, the development of lefamulin for additional indications, the development of additional formulations of lefamulin, plans to pursue research and development of other product candidates, the sufficiency of Nabriva’s 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’s first Phase 3 clinical trial of lefamulin will be indicative of the results for its second Phase 3 clinical trial of lefamulin, 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 and quarterly reports on file with the