The company is developing both intravenous and oral formulations of lefamulin for the treatment of community-acquired bacterial pneumonia (CABP), and intends to develop lefamulin for additional indications, as well.
Attributes that make lefamulin a potential first-line antibiotic for CABP include its broad spectrum of activity, its potential for slow development of bacterial resistance over time, its convenient dosing regimen, and its favorable safety and tolerability profile, the company said.
Nabriva has started two registrational global Phase 3 clinical trials examining treatment with lefamulin in patients with a diagnosis of moderate-to-severe CABP.
During the ASM Microbe 2016 Conference June 16-20 in Boston, the company presented data of a study titled “In Vitro Activity of Lefamulin Against Macrolide-Susceptible (MSMP) and Macrolide-Resistant Mycoplasma pneumoniae (MRMP) from the United States, Europe, and China” (Abstract 3972). In the study, lefamulin and four antibiotics (azithromycin, erythromycin, moxifloxacin, and tetracycline) were tested against 50 Mycoplasma pneumoniae isolates, including 36 macrolide-resistant isolates, obtained between 2009 and 2013 in the U.S. and China.
M. pneumoniae is a pathogenic mycoplasma responsible for respiratory tract infections in humans, which occurs worldwide in children and adults.
The study’s results demonstrated lefamulin’s exceptional in vitro activity against all M. pneumoniae tested isolates, which was unaffected by resistance to macrolides, a class of natural antibiotics widely used against M. pneumoniae.
“Mycoplasma pneumonia is a major cause of CABP, estimated to be responsible for up to 50 percent of cases in children. Clinicians are concerned with the increasing prevalence of clinically significant resistance to macrolides in M. pneumoniae, spreading from Asia and Europe to the United States,” said Ken B. Waites, M.D., F(AAM), professor of pathology and director of the Diagnostic Mycoplasma Laboratory at the University of Alabama at Birmingham, in a press release.
“These data demonstrate potent in vitro activity of lefamulin against all strains of M. pneumoniae tested regardless of resistance phenotype. Further assessment of lefamulin for the treatment of respiratory infections caused by M. pneumoniae is warranted,” he said.
“Lefamulin has consistently demonstrated potent in vitro activity against the most common gram-positive, gram-negative, and atypical bacterial causes of CABP, including multi-drug resistant strains. The data reported at ASM add to the robust in vitro evidence supporting the potential of this promising agent in the treatment of CABP,” said Steve Gelone, Pharm.D., Nabriva’s chief development officer.
“We continue to enroll patients in our Phase 3 development program with moderate-to-severe CABP, and based on our progress, we remain on track to report top-line data in the second half of 2017,” Gelone added.
For more information about the Phase 3 trial and how to participate, please visit this link.
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