Nabriva Therapeautics have announced positive results from their Phase 3 trial of lefamulin in patients with community-acquired bacterial pneumonia (CABP). 

A total of 551 adults with moderate to severe CABP were included in the randomized, controlled, double-blind, global ‘LEAP 1’ study, which compared lefamulin to moxifloxacin with or without linezoid. Two hundred and seventy-six patients were in the lefamulin group, dosed at 150mg IV every 12 hours, while there were 275 in the moxifloxacin group, dosed according to its label: 400mg IV daily, and linezolid at 600mg IV every 12 hours.  

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The results showed that the primary endpoint of non-inferiority to moxifloxacin with or without linezoid was met with an early clinical response rate of 87.3% for lefamulin and 90.2% for moxifloxacin with or without linezoid (treatment difference -2.9, CI 95%, -8.5, 2.8).

“These Phase 3 data provide strong evidence of the potential of lefamulin to treat adults with CABP and provide an alternative to a current gold standard treatment regimen,” said Dr. Colin Broom, chief executive officer of Nabriva Therapeutics. A second ‘LEAP 2’ trial is currently in the midst of enrolling patients and expected to have topline results in the spring of 2018.

A similar rate of treatment-emergent adverse events (TEAEs) in the LEAP 1 trial was observed in the lefamulin arm (38.1%) compared to the moxifloxacin with or without linezolid arm (37.7%).

The company stated that further results from the trial including secondary and exploratory endpoints will be presented at upcoming scientific congresses.

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