Nabriva Therapeutics plc (NASDAQ:NBRV) reported positive topline data from the lefamulin assessment against pneumonia (LEAP 1) study, which assessed the efficacy and safety of intravenous to oral lefamulin in people with community-acquired bacterial pneumonia. CABP is the major cause of infectious death in the U.S.
In the LEAP 1 study, Nabriva’s first of two pivotal Phase III clinical studies of lefamulin in people with CABP, lefamulin achieved the U.S. FDA primary goal of non-inferiority as against moxifloxacin without or with adjunctive linezolid for ECR assessed 72 to 120 hours after start of treatment in the intent to treat patient population. In the study, ECR rates came at 90.2% for moxifloxacin and 87.3% for lefamulin without or with linezolid.
Dr. Colin Broom, the CEO, expressed that these Phase III data offer strong evidence of the prospect of lefamulin to treat people with CABP and offer an alternative to an existing gold standard treatment plan. Following lefamulin’s flexible dosing and intended spectrum of activity against the pathogens commonly related with CABP, counting multidrug-resistant strains, they consider believe that lefamulin is extremely suited to turn a first-line empiric monotherapy.
The CEO of Nabriva expressed that he is extremely appreciative and proud of the company’s team that has developed lefamulin, which has the prospect to be the first in a latest class of antibiotics for community-acquired bacterial pneumonia in over 15 years, from initial discovery in their labs to this major milestone. They continue to execute on their second pivotal study assessing oral lefamulin for the cure of CABP, with enrollment anticipated to complete in Q4 2017 and topline data expected in the spring of 2018.
In the last trading session, the stock price of Nabriva jumped more than 29% to close the day at $8.87. The gains came at a share volume of 17.49 million compared to average share volume of 74,701.