Nabriva Therapeutics (NASDAQ:NBRV) reported positive top-line results from its LEAP 2 clinical trial, the second of two global, Phase 3 clinical trials of its antibiotic, lefamulin.
LEAP 2 evaluated the safety and efficacy of five days of oral lefamulin, compared with seven 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 trial, LEAP 1, in which intravenous-to-oral lefamulin was found to be non-inferior to IV-to-oral moxifloxacin, with or without linezolid.
“Today marks an exciting advance in the treatment of CABP as we are one step closer to potentially making a much-needed new class of antibiotics available to patients and health care providers,” Dr. Jennifer Schranz, CMO, said in a statement.
“Lefamulin has the potential to be the first-in-class pleuromutilin antibiotic available for IV or oral administration, and results from LEAP 2 provide additional evidence of its efficacy and tolerability in the treatment of adult patients with CABP,” she added
Dr. Colin Broom, CEO, said that coupled with the 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.
“We are especially pleased with the high response rates for lefamulin in LEAP 1 and LEAP 2 and plan to file a NDA with the FDA in the fourth quarter of 2018,” he added.
