Oral lefamulin (Nabriva Therapeutics) was found to be non-inferior to moxifloxacin for early clinical response (ECR) in patients with moderate community-acquired bacterial pneumonia (CABP), according to results from the Phase 3 LEAP 2 clinical trial.
Lefamulin is a novel semi-synthetic pleuromutilin antibiotic with the potential to be the first-in-class available for systemic administration in humans. Results from a previous Phase 3 study (LEAP 1) showed that intravenous to oral lefamulin was found to be non-inferior to IV to oral moxifloxacin with or without linezolid.
In the LEAP 2 study (N=738), patients with moderate CABP received either oral lefamulin 600mg every 12 hours for 5 days or oral moxifloxacin 400mg once daily for 7 days. ECR was assessed at 72 to 120 hours following initiation of therapy in the intent-to-treat (ITT) patient population; results showed that both the lefamulin and moxifloxacin groups had an ECR of 90.8%. (treatment difference: 0.1; 95% CI, -4.4, 4.5).
“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,” said Dr. Colin Broom, chief executive officer of Nabriva Therapeutics. “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.”
For more information visit Nabriva.com.