Successful Chinese Phase III Bridging Trial of New Antibiotics

Article source: Medical Rubik's Cube Info

On May 25, Lunsheng Pharmaceutical and Nabriva announced that the Phase III bridging trial of lefamulin (pleuromutilin acetate) in China for the treatment of adult community-acquired bacterial pneumonia (CABP) has achieved positive results.

In the United States, lefamulin is sold by Nabriva under the trade name Xenleta.

This bridging phase III study is a multicenter, randomized, double-blind controlled trial designed to compare the safety and effectiveness of 125 CABP patients receiving lefamulin intravenous (IV) versus oral vs.

In the modified intention-to-treat (mITT) population, lefamulin reached the primary endpoint of non-inferiority to moxifloxacin, and the lefamulin group and moxifloxacin group were successfully assessed by the investigator's clinical response (IACR-TOC) at the time of TOC.

Lefamulin is generally safe and well tolerated, consistent with previously reported clinical trial results, and the total incidence of treatment emergent adverse events (TEAEs) is comparable to moxifloxacin.

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