Nabriva's lefamulin meets in Phase III LEAP 2 trial for CABP

Nabriva Therapeutics plc (NASDAQ:NBRV) reported a higher incidence of GI adverse events in patients who received oral lefamulin (BC-3781) in the Phase III LEAP 2 trial to treat moderate community-acquired bacterial pneumonia (CABP). While the trial met both the FDA- and EMA-defined primary endpoints, there were more reports of diarrhea (12.2% vs. 1.1%), nausea (5.2% vs. 1.9%) and vomiting (3.3% vs. 0.8%) in patients who received lefamulin compared with moxifloxacin.

Among 738 patients in the intent-to-treat (ITT) population of LEAP 2, twice-daily 600 mg lefamulin for five days was non-inferior to once-daily oral moxifloxacin for seven days on the FDA-defined primary endpoint of early clinical response at 72-120 hours after the start of treatment (90.8% for both). The non-inferiority margin was 10%. Early clinical response was defined as improvement in at least two of the four 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...