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Nabriva Therapeutics' pneumonia antibiotic succeeds in late-stage study

Nabriva Therapeutics PLC said the phase 3 trial of oral lefamulin in community-acquired bacterial pneumonia met its main goal.

Pneumonia is an infection of the lungs in which the tiny air sacs, or alveoli, inside the lungs fill up with fluid.

The study, known as LEAP 2, showed that a five-day treatment regimen of lefamulin worked as well as a seven-day regimen of oral moxifloxacin.

Moxifloxacin, also marketed as Avelox by Bayer AG, is an antibiotic used to treat various bacterial infections and is part of the World Health Organization's list of essential medicines.

The drug also met the main goal under the European Medicines Agency's criteria of matching moxifloxacin's clinical response among patients.

Lefamulin had cleared another phase 3 study in 2017 in which a combination of the injectable and oral version of the drug worked as well as similar versions of moxifloxacin.

The company plans to file a new drug application for Lefamulin with the U.S. Food and Drug Administration in the fourth quarter of 2018.

Dublin-based Nabriva said pneumonia is the leading cause of infection-related deaths and the second leading cause of total hospitalizations in the U.S.