Nabriva Therapeutics has reported positive topline results from its Lefamulin Evaluation Against Pneumonia (LEAP 2) clinical trial, which examined the safety and efficacy of lefamulin against oral moxifloxacin in adult patients with moderate community-acquired bacterial pneumonia (CABP).
LEAP 2 is the second of two global, pivotal Phase lll clinical trials of lefamulin conducted by Nabriva.
The randomised, double-blind, double-dummy trial compared the efficacy and safety of 600mg of oral lefamulin twice a day for five days versus 400mg of oral moxifloxacin once daily for seven days in 738 patients.
The lefamulin arm enrolled 183, 145, and 40 patients with a Pneumonia Outcomes Research Team (PORT) class of 2, 3 and 4, respectively, while the moxifloxacin arm included 189, 133, and 42 patients with a PORT class of 2, 3 and 4, respectively.
Nearly all the patients completed the study through late follow-up, which took place 30 days after administration of the first dose of lefamulin.
The LEAP 2 trial met the US Food and Drug Administration (FDA) primary endpoint of non-inferiority compared to moxifloxacin for early clinical response (ECR) evaluated 72 to 120 hours after the beginning of therapy in the intent-to-treat (ITT) patient population.
It also met the European Medicines Agency (EMA) primary endpoint for non-inferiority against moxifloxacin based on an investigator assessment of clinical response (IACR) five to ten days following the completion of the dosing of lefamulin in the modified intent to treat (mITT) and clinically evaluable at test of cure (CE-TOC) patient populations.
Nabriva Therapeutics chief medical officer Dr Jennifer Schranz said: “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.
“We believe lefamulin is well-suited for the empiric treatment of CABP given its short-course regimen, novel mechanism of action, targeted spectrum of activity against the most common and problematic CABP pathogens, and its safety and tolerability profile.”