- Nabriva Therapeutics announced Monday morning that a Phase 3 trial of oral lefamulin outperformed oral moxifloxacin in adult patients with moderate community-acquired bacterial pneumonia (CABP).
- The LEAP2 study tested the safety and efficacy of five days of lefamulin versus seven days of moxifloxacin, showing lefamulin was non-inferior for early clinical response assessed 72 to 120 hours following initiation of therapy in the intent-to-treat patient population.
- Early clinical response was 90.8% for the five-day treatment course of lefamulin and 90.8% for the seven-day treatment course of moxifloxacin.
The positive results from the LEAP2 study, as well as positive results from an earlier Phase 3 study that tested intravenous-to-oral lefamulin, have Nabriva ready to file for for approval in both the U.S. and EU. The company said it expects to turn in its New Drug Application to the Food and Drug Administration some time in the fourth quarter.
The drug could be a new option for treatment of bacterial infections as antibiotic resistance continues to rise. According to the Centers for Disease Control and Prevention, more than 2 million illnesses are caused by antibiotic resistance, and 14,000 deaths annually. Most of these infections occur in healthcare settings like hospitals and tend to affect high-risk populations like the elderly.
Lefamulin is of a new class of drugs called pleuromutilin antibiotics, which block a protein vital for bacteria to grow.
"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 Colin Broom, chief executive officer of Nabriva.
Nabriva's stock was up 17% in pre-market trading, but quickly reversed once the market opened, and is trading down about 12% in the Monday morning session.
While the results were positive, investors may have been looking for an even better result of superiority over the commonly used moxifloxacin.
The antibiotic was generally well tolerated in the study, with similar rates of adverse events, as well as study discontinuations between the treatment and control arms. Nabriva is still evaluating data from the study and expects to report the full data set at an upcoming medical meeting.