Nabriva Therapeutics PLC (NBRVF)

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Nabriva Therapeutics Commends the CDC on the 2019 Antibiotic Resistance Threats Report, Highlighting the Need for New Antibiotics Aligned with Antibiotic Stewardship
2019-11-18 07:00:00 AM ET (GlobeNewswire)
   
   
-- S. pneumoniae continues to be designated by the CDC as "Serious Threat" underscoring need for rapid detection and prevention strategies, particularly in community setting

-- XENLETA(TM) has a novel mechanism of action that is different than all other antibiotics, has been shown to be associated with a very low rate of resistance, and no cross resistance with other antibiotics commonly prescribed for community-acquired bacterial pneumonia

-- First oral and IV antibiotic in the pleuromutilin class offers a targeted spectrum, short-course treatment option to fight drug-resistant pathogens, including S. pneumoniae

Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, emphasized the significance of the new updated report from the Centers for Disease Control and Prevention (CDC) concerning the rise of antibiotic resistance. Nabriva specifically commended the CDC for recognizing the need to do more in the community setting where rapid detection and prevention strategies can help curb the "serious threat" of drug-resistant Streptococcus pneumoniae. XENLETA(TM) (lefamulin), the first oral and IV treatment in the pleuromutilin class, is indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) which affects more than five million Americans. CABP is associated with significant morbidity and mortality, and XENLETA provides a critically needed alternative treatment option to reduce the growing resistance to commonly prescribed treatments for this serious infectious disease.

"Pneumonia is the fifth leading cause of hospitalization and one of the leading causes of infection-related death in the U.S. each year," said Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics. "We applaud the CDC for reinforcing the need to do more to prevent and rapidly diagnose CABP. It is also important to recognize that significant progress in antibiotic drug development has been achieved- including the FDA approval of XENLETA, the first new class of antibiotic approved by the FDA in nearly 20 years. XENLETA provides physicians a treatment option that works differently than older antibiotics, is available in oral and IV formulations, and has been shown to be effective as a short course therapy - all critical components aligned with the core principles of antibiotic stewardship highlighted by the CDC. Nabriva remains committed to continuing to develop innovative anti-infective treatments, like XENLETA, that address the growing antibiotic threats identified by the CDC."

CABP is a lung infection and the most common type of pneumonia that occurs outside of hospitals or other health care facilities. Rising resistance rates to current commonly used antibiotic treatments for CABP poses a serious threat to patients. Streptococcus pneumoniae is the most common cause of bacterial pneumonia in the U.S., and approximately 30 to 60 percent of S. pneumoniae, depending on region, are resistant to macrolide antibiotics. In the 2019 report, the CDC links drug-resistant S. pneumoniae to 900,000 infections and 3,600 deaths annually.

Given the increasing rate of drug resistance to macrolides and safety concerns related to fluoroquinolones and beta-lactams, XENLETA offers CABP patients an effective and well tolerated alternative treatment option with the potential to address the limitations of existing agents. XENLETA has a novel mechanism of action that targets a binding site on bacteria that is different from existing antibiotics which has been shown to result in no cross resistance to other antibiotic classes commonly prescribed for CABP and a low potential for the development of resistance. XENLETA is also convenient for patients being treated in the hospital, transitioning treatment out of the hospital or initiating treatment in the community.

"New antibacterial treatments that have a truly novel mechanism of action are critical to address the serious public health threat posed by antibiotic resistance, especially for patients with CABP," said Jennifer Schranz, MD, Chief Medical Officer of Nabriva. "World Antibiotic Awareness Week is November 18-24, 2019, providing an opportune time to engage and encourage clinicians, policy makers, and the public to do their part to reduce the emergence and spread of this important public health threat."

About CABP

Pneumonia is an infection of the lung that can be serious and fatal, especially among older adult patients with comorbidities. There are approximately five million cases of pneumonia in the U.S. each year, and pneumonia is the fifth leading cause of hospitalization and one of the leading causes of infection-related death. Streptococcus pneumoniae is the most common cause of bacterial pneumonia in the U.S. According to recent data from the SENTRY Antimicrobial Surveillance Program, in the U.S., approximately 30 to 60 percent of S. pneumoniae, depending on region, are macrolide resistant. In addition to macrolides, fluoroquinolones are another common treatment option for CABP. This broad-spectrum class is an effective option, however fluoroquinolones carry boxed warnings for several significant safety concerns.

About XENLETA

XENLETA (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 plc

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), the first pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing Contepo (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis. For more information, please visit https://www.nabriva.com.