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Positive Results for Pleuromutilin Antibiotic in CABP-LEAP 2 Trial


Positive Results for Pleuromutilin Antibiotic in CABP-LEAP 2 Trial

Positive top-line results from the second global phase 3 clinical trial of lefamulin, for the treatment of adults with community-acquired bacterial pneumonia (CABP), released by biopharmaceutical company, Nabriva Therapeutics. Lefamulin was found non-inferior to moxifloxacin for an early clinical response (ECR) in patients with CABP.

Two pivotal Phase 3 trials have been completed evaluating the safety and efficacy of lefamulin for the treatment of adults with CABP. In their first clinical trial in patients with CABP (LEAP-1), seven-days of intravenous (IV) to oral lefamulin in adults with moderate to severe CABP was compared to moxifloxacin (IV/oral), with or without linezolid.  In the LEAP 2 trial, five-days of oral lefamulin was compared to seven-days of oral moxifloxacin in adults with moderate CABP.  Both trials were multi-center, randomized, controlled and double-blind. Lefamulin met all FDA and EMA primary endpoints in both LEAP 1 and LEAP 2 and was shown to be generally well tolerated

LEAP 2 evaluated the safety and efficacy of 5 days of oral lefamulin compared to 7 days of oral moxifloxacin in adult patients with moderate community-acquired bacterial pneumonia (CABP). In September 2017, the company announced positive results from its first Phase 3 clinical trial, in which intravenous (IV) to oral lefamulin was found to be non-inferior to IV to oral moxifloxacin with or without linezolid.

LEAP 2 was a global, randomized, double-blind, double-dummy trial that compared the efficacy and safety of 600 mg of oral lefamulin twice a day for 5 days versus 400 mg of oral moxifloxacin once daily for 7 days in 738 patients (370 in the lefamulin arm and 368 in the moxifloxacin arm).  The lefamulin arm enrolled 183 (49.5%), 145 (39.2%) and 40 (10.8%) patients with a Pneumonia.

In this trial, lefamulin was generally well tolerated. In LEAP 2, lefamulin met the U.S. Food and Drug Administration (FDA) primary endpoint of non-inferiority compared to moxifloxacin for an early clinical response (ECR) assessed 72 to 120 hours following initiation of therapy. ECR was 90.8% for the 5-day treatment course of lefamulin and 90.8% for the 7-day treatment course of moxifloxacin.

 The rate of treatment-emergent adverse events (TEAEs) was 32.6% in the lefamulin arm and 25.0% in the moxifloxacin arm.  A low percentage of patients discontinued study drug in the lefamulin arm (6.8%) and in the moxifloxacin arm (7.6%).  TEAEs leading to discontinuation of study drug were uncommon and were observed in 3.0% of patients in the lefamulin arm and 2.2% of patients in the moxifloxacin arm.

Adverse events reported were diarrhea/loose stools, nausea, vomiting, hypertension, headache, gastritis and urinary tract infection.

Further analysis of the LEAP 2 trial results including analysis of additional patient population groups in the trial and secondary and exploratory endpoints related to these population groups is ongoing.

“Coupled with our successful LEAP 1 trial, the positive results from LEAP 2 suggest lefamulin could be an excellent empiric treatment option for patients with CABP and help address the problem of antibiotic resistance.  With these LEAP 2 results, we believe there is a significant opportunity for oral lefamulin as a 5-day treatment option for CABP in the community,” said Dr. Colin Broom, the chief executive officer of Nabriva Therapeutics

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Vinay Singh

Vinay Singh

Vinay Singh joined Medical Dialogue as Desk Editor in 2018. He covers the medical speciality news in different medical categories including Medical guidelines, updates from Medical Journals and Case Reports. He completed his graduation in Biotechnology from AAIDU and did his MBA from IILM Gurgaon. He can be contacted at editorial@medicaldialogues.in . Contact no. 011-43720751
Source: press release

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