Nabriva Therapeutics Plc (NASDAQ:NBRV) shares were seen higher on Monday after the drug developer revealed positive results for a Phase 3 drug trial of a potential treatment for community-acquired bacterial pneumonia (CABP).
The company, in a statement, highlighted that CABP is the leading cause of infectious death in the United States and that the trial has provided “strong evidence” of the potential of its drug, called Lefamulin.
The drug met the US Food and Drug Administration (FDA) primary endpoint of non-inferiority compared to current treatment moxifloxacin, and it added that early clinical response (ECR) rates were 87.3% for lefamulin and 90.2% for moxifloxacin.
Dr Colin Broom, Nabriva chief executive, said: “These Phase 3 data provide strong evidence of the potential of lefamulin to treat adults with CABP and provide an alternative to a current gold standard treatment regimen.”
“Due to lefamulin’s flexible dosing and targeted spectrum of activity against the pathogens most commonly associated with CABP, including multidrug-resistant strains, we believe that lefamulin is well suited to be a first-line empiric monotherapy.”
Nabriva is separately advancing another trial which is due to complete enrolment in the fourth quarter, with topline results anticipated by spring 2018.
Bloom added: “I am extremely proud and appreciative of the Nabriva Therapeutics team that has advanced lefamulin, which has the potential to be the first in a new class of antibiotics for CABP in more than 15 years, from initial discovery in our labs to this important milestone.
Later in the day, shares added almost 42% to US$9.74.