Updated
May 23rd, 2018

Oral Lefamulin Met Study’s Endpoints for CABP

Nabriva's Lefamulin reaches primary endpoints in LEAP 2 phase 3 study of Community-Acquired Bacterial Pneumonia

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An innovative biopharmaceutical company announced positive results from its Lefamulin Evaluation Against Pneumonia (LEAP 2) clinical trial. 

This is the second of two global, pivotal Phase 3 clinical trials of Lefamulin. 

The LEAP 2 study evaluated the safety and efficacy of 5 days of oral lefamulin compared to 7 days of oral moxifloxacin in adult patients with moderate community-acquired bacterial pneumonia (CABP).

LEAP 2 was a global, randomized, double-blind, double-dummy trial that compared the efficacy and safety of 600 mg of oral lefamulin twice a day for 5 days versus 400 mg of oral moxifloxacin once daily for 7 days.

In LEAP 2, Lefamulin met the U.S. Food and Drug Administration primary endpoint of non-inferiority compared to moxifloxacin for early clinical response (ECR) assessed 72 to 120 hours following initiation of therapy in the intent to treat patient population.

ECR was 90.8 percent for the 5-day treatment course of Lefamulin and 90.8 percent for the 7-day treatment course of moxifloxacin.

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Pneumonia is an infection that inflames the air sacs in one or both lungs. A variety of organisms, including bacteria, viruses, and fungi, can cause pneumonia, says the Mayo Clinic. 

Pneumonia can range in seriousness from mild to life-threatening. It is most serious for infants and young children, people older than age 65, and people with health problems or weakened immune systems.

Dr. Jennifer Schranz, Chief Medical Officer of Nabriva Therapeutics said, “We believe lefamulin is well-suited for the empiric treatment of CABP given its short-course regimen, novel mechanism of action, the targeted spectrum of activity against the most common and problematic CABP pathogens, and its safety and tolerability profile.”

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“Pneumonia is the leading cause of infection-related deaths and the second leading cause of total hospitalizations in the United States,” said Andrew Shorr, MD, MPH, MBA, at Georgetown University.

“As bacterial resistance continues to increase, there is an urgent need for new, safe, and effective IV and oral treatment options for CABP. The positive topline results from LEAP 1 and LEAP 2 indicate that lefamulin could provide health care providers with a new potential option in the treatment of CABP across the spectrum of care, ranging from the hospital to the community,” said Dr. Shorr.

"Macrolide antibiotics, including clarithromycin (Biaxin &reg), and doxycycline, are favored for outpatient management of adults with community-acquired pneumonia" according to the CDC.

Nabriva Therapeutics is a biopharmaceutical company engaged in the research and development of new medicines to treat serious bacterial infections, with a focus on the pleuromutilin class of antibiotics.

Vaccines help prevent pneumococcal disease, which is any type of infection caused by Streptococcus pneumoniae bacteria.

There are two kinds of pneumococcal vaccines available in the United States:

  • Pneumococcal conjugate vaccine
  • Pneumococcal polysaccharide vaccine

Most pharmacies offer vaccines.

Private vaccination appointment can be scheduled here.