Nabriva's lefamulin meets in Phase III LEAP 1 trial for CABP

Nabriva Therapeutics plc (NASDAQ:NBRV) reported that IV-to-oral lefamulin (BC-3781) met the FDA- and EMA-defined primary endpoints in the double-blind, international Phase III LEAP 1 trial to treat moderate to severe community-acquired bacterial pneumonia (CABP). Top-line data from the Phase III LEAP 2 trial evaluating oral lefamulin to treat CABP are expected next spring, with an NDA submission to FDA to follow in 2H18. The company plans to submit an MAA to EMA “within a few months” after its NDA submission.

In LEAP 1's 551-patient intent-to-treat (ITT) population, 150 mg lefamulin every 12 hours was non-inferior to moxifloxacin with or without adjunctive Zyvox linezolid on the FDA-defined primary endpoint of early clinical response at 72-120 hours after the start of treatment (87.3% vs. 90.2%). The non-inferiority margin was 12.5%. Early clinical response was defined as improvement in ≥2 of the 4 cardinal symptoms of CABP -- difficulty breathing, cough, production of purulent sputum and chest pain -- with no worsening in any of those symptoms or use of a concomitant antibiotic (other than linezolid). Investigators could switch patients to 600 mg oral lefamulin every 12 hours after 3 days of IV treatment...