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Lefamulin meets primary endpoints in LEAP 1 trial
November 2017
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DUBLIN & KING OF PRUSSIA, Pa.—Biopharmaceutical company Nabriva Therapeutics plc shared positive top-line results in September regarding its lefamulin evaluation against pneumonia (LEAP 1) trial assessing the safety and efficacy of intravenous to oral lefamulin in individuals with community-acquired bacterial pneumonia. Lefamulin met the U.S. Food and Drug Administration (FDA) primary endpoint of non-inferiority compared to moxifloxacin with or without adjunctive linezolid for early clinical response (ECR) assessed 72 to 120 hours following the start of therapy in the intent to treat patient population. ECR rates were 87.3 percent for lefamulin and 90.2 percent for moxifloxacin with or without linezolid. In addition, Lefamulin met the EMA primary endpoints for non-inferiority and clinically evaluable at test of cure populations based on an investigator assessment of clinical response (IACR) at a test of cure visit. IACR is also a secondary FDA endpoint.

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