Nabriva Therapeutics PLC (NBRVF)

[John-Knee]

Lefamulin Demonstrates Anti-Inflammatory Activity in Pre-Clinical Study
2020-07-23 07:05:03 AM ET (GlobeNewswire)
   
   
-In pre-clinical model, lefamulin shows anti-inflammatory activity comparable to dexamethasone

-Nabriva awarded grant funding from the Austrian Research Promotion Agency to further characterize the anti-inflammatory and immunomodulatory properties of Lefamulin

Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today the results of a pre-clinical study demonstrating potent anti-inflammatory activity of lefamulin. In a mouse model of lipopolysaccharide (LPS) induced lung neutrophilia, lefamulin showed anti-inflammatory properties similar to dexamethasone, a corticosteroid commonly used for its anti-inflammatory and immunomodulatory properties. Lefamulin, the company's novel pleuromutilin antibiotic, is approved by the U.S. Food and Drug Administration (FDA) under the brand name XENLETA(R) for the treatment of community-acquired bacterial pneumonia (CABP) in adults. XENLETA is the first IV and oral antibiotic with a novel mechanism of action approved by the FDA in nearly two decades. The study was accepted as a pre-print manuscript in bioRxiv.

The research findings reflect the first study investigating the anti-inflammatory activity of lefamulin. In the mouse model of LPS induced lung neutrophilia, pretreatment with lefamulin at doses of 35, 70, and 140 mg/kg administered subcutaneously (SC) 30 minutes before intranasal LPS administration challenge was associated with almost complete reduction in total cell and neutrophil recruitment to the lungs at 4 hours post challenge compared with the vehicle control group (no treatment). Importantly, lefamulin demonstrated reductions in total cell and neutrophil counts that were similar to those observed with dexamethasone at all lefamulin doses tested.

Nabriva has also been awarded grant funding from the Austrian Research Promotion Agency (FFG) as part of their "Emergency Call for COVID-19" research. This funding will support additional in vitro and animal experiments designed to investigate and further characterize the anti-inflammatory and immunomodulatory properties of lefamulin, as well as our proprietary library of pleuromutilin compounds.

"The anti-inflammatory effect lefamulin demonstrated in this study is very encouraging," said Jennifer Schranz, MD, Chief Medical Officer of Nabriva. "Inflammation complicates several pulmonary diseases including pneumonia and contributes substantially to morbidity and mortality in patients. We are excited to partner with the FFG to further investigate the anti-inflammatory and immunomodulatory properties of lefamulin and its potential application to inflammatory pulmonary diseases."

Complete findings of the study titled "Anti-inflammatory Activity of Lefamulin in a Lipopolysaccharide-Induced Lung Neutrophilia Model" is available online at: https://www.biorxiv.org/content/10.1101/2020.06.23.168393v1.full.pdf. Additional details about the FFG and the emergency call for COVID-19 research can be found at https://www.ffg.at/en/news/corona-call.

About XENLETA

XENLETA(R) (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. XENLETA's binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Efficacy of XENLETA was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP. In these trials, XENLETA was compared with moxifloxacin and in one trial, moxifloxacin with and without linezolid. Patients who received XENLETA had similar rates of efficacy as those taking moxifloxacin alone or moxifloxacin plus linezolid. The most common adverse reactions associated with XENLETA include diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting.

About Nabriva Therapeutics

Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). XENLETA was discovered in Nabriva Therapeutics laboratories in Vienna, Austria. For more information, please visit www.nabriva.com.

About the Austrian Research Promotion Agency (FFG)

The Austrian Research Promotion Agency (FFG) is the national funding agency for industrial research and development in Austria. The purpose of the FFG is to promote research, technology, development and innovation for the benefit of Austria. All FFG activities aim to strengthen Austria as a research and innovation center on the global market and thus help to ensure the long-term availability of high-quality jobs and maintain the prosperity of one of the world's wealthiest countries. For more information, please visit https://www.ffg.at/en.