Nabriva Therapeutics recently announced that it will present two posters on the company’s clinical-stage antibiotic, lefamulin, currently being developed for the treatment of community acquired bacterial pneumonia (CABP).
The data will be presented at IDWeek Conference, taking place in New Orleans starting Wednesday and running through Oct. 30.
Nabriva is focused on developing a pleuromutilin class of antibiotics to treat serious infections. Lefamulin is a semi-synthetic compound that inhibits the synthesis of bacterial proteins, required for bacteria to grow. Lefamulin acts by binding to the peptidyl transferase center (PTC) on the bacterial ribosome, in a way that interferes with protein synthesis. This process results in the inhibition of bacterial protein production and bacterial growth.
Lefamulin belongs to the first new class of antibiotics (pleuromutilins) to reach late stage clinical testing as a CABP treatment in over 10 years. The drug has anti-microbial activity against pathogens commonly associated with CABP, such as the multi-drug resistant Streptococcus pneumoniae and Staphylococcus aureus.
Nabriva is currently conducting two comparative and double-blind Phase 3 clinical trials to investigate lefamulin (against the antibiotics moxifloxacin and, possibly, linezolid) in patients with moderate-to-severe CABP: LEAP (NCT02559310) and LEAP2 (NCT02813694). Both trials are currently enrolling patients at sites in the U.S., or the U.S., Europe and elsewhere; more information is available by clicking on each’s trials identification number.
At IDWeek Conference, the company will present these posters at the Antimicrobial Pharmacokinetics and Pharmacodynamics Session set for Oct. 29:
- Poster #1944: “Population Pharmacokinetic (PPK) Analysis for Lefamulin Using Phase 1 Data and Assessment of Optimal PK Sampling Strategies (OSS) for a Phase 3 Community-Acquired Bacterial Pneumonia (CABP) Study”
- Poster #1976: “Pharmacokinetic-Pharmacodynamic (PK-PD) Target Attainment Analyses to Support Oral Lefamulin Dose Selection in the Treatment of Patients with Community-Acquired Bacterial Pneumonia (CABP)”
Their data focus on the pharmacokinetic and pharmacokinetic-pharmacodynamic models of the drug, namely concerning regimen, doses, absorption rate, bioavailability, and fasting/non-fasting conditions.
“Our presentations at IDWeek support the pharmacokinetic-pharmacodynamic rationale for selection of the IV [intravenous] and oral dosing in our current Phase 3 program for lefamulin for the treatment of CABP,” Steve Gelone, PharmD, Nabriva’s chief development officer, said in a press release. “We are looking forward to further discussions at the conference and continuing to provide data that differentiates the first systemic pleuromutilin product candidate for the clinical and research communities.”
IDWeek 2016 is the joint annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS).