Lefamulin Returns Positive Phase 3 Results for Pneumonia

In time for fall and winter seasons, an investigational monotherapy for pneumonia is returning positive topline results from a phase 3 trial.

Lefamulin, as an oral and intravenous (IV) therapy, met all primary US Food and Drug Administration (FDA) and European Medicines Agency (EMA) endpoints in treating community acquired bacterial pneumonia (CABP), the leading cause of infectious deaths in the US for over a decade.

The treatment, which in trials was combined with IV in CABP patients, represents the first new class of positive-results trial antibiotics for pneumonia, according to Nabriva Therapeutics.

Investigator Thomas File, MD, chair of the Infectious Disease Section at Northeast Ohio Medical University, told MD Magazine just how needed antibiotics are for CABP.

“If you look at data, for patients admitted to hospital, the mortality in patients over 65 (years old) is 12%,” File said. “It’s obviously a significant infection.”

CABP currently has just 2 recommended therapies via practice guidelines, File said, and one recommended monotherapy could lead to adverse effects in patients.

In lefamulin’s phase 3 trial, LEAP 1, the antibiotic met primary endpoint of non-inferiority compared to moxifloxacin with or without adjunctive linezolid for early clinical response (ECR) — as assessed 3 to 5 days following initiation of therapy. Lefamulin returned a 87.3% ECR rate, versus moxifloxacin’s 90.2% with or without linezolid.

The investigational drug similarly returned positive safety results. Moxifloxacin is linked to effects such as diarrhea and other gastroenterological conditions such as Clostridium difficile, File said.

There is further analysis ongoing in from the LEAP 1 trial. Its successor LEAP 2 trial is expected to detail the efficacy of lefamulin’s oral form for CABP when it’s released in early 2018. File noted that patients’ ability to switch from IV to oral therapy, or vice versa, provides a “convenient aspect” of the drug.

Lefamulin’s flexible dosing and targeted spectrum of activity “against the pathogens most commonly associated with CABP” makes it well-suited to become a first-line monotherapy, Dr. Colin Broom, chief executive officer of Nabriva, said.

“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,” Broom said.

A press release regarding the study was made available.