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Nabriva On Pace For Lefamulin NDA; Stock Tumbles Despite Trial Success

 
• By Joseph Haas

With a pair of Phase III trials demonstrating lefamulin’s non-inferiority to moxifloxacin in CABP, Nabriva plans to file an NDA later this year. But Nabriva’s share price fell during the day, perhaps due to safety concerns about the first-in-class antibiotic.

woman in a laboratory microscope with microscope slide in hand.toned image.

In a stark example of a good news/bad news day, Nabriva Therapeutics PLC reported positive top-line data from a second Phase IIl trial for its novel antibiotic lefamulin in community-acquired bacterial pneumonia (CABP) on May 21, but by day’s end its share price tumbled after rising on the clinical data success earlier in the day.

Despite hitting all clinical endpoints recommended by US FDA and the European Medicines Association in both the LEAP 1 and LEAP 2 studies, the latter study with an oral version of lefamulin, a first-in-class pleuromutilin antibiotic, investors may have soured on the firm’s prospects during the day after perusing safety data from LEAP 2. Lefamulin demonstrated non-inferiority to moxifloxacin, with or without linezolid, for early clinical response in the LEAP 1 study, but the safety and tolerability findings of the two pivotal trials presented clear differences

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