The Unmet Need
Community-acquired bacterial pneumonia, or CABP, and acute bacterial skin and skin structure infections, or ABSSSI, are important public-health concerns due to increasing drug resistance of established antibiotics to causative pathogens. Due to the emerging resistance to established antibiotics, there is a large unmet need for antibiotics that cover a broad range of pathogens, including resistant Staphylococcus (“Staph”) and Streptococcus (“Strep”). Bacterial infections are a major cause of morbidity and mortality. Global microbiological surveillance suggests that approximately 40% of Staph infections in the U.S., Latin America and Asia Pacific are methicillin-resistant Staphylococcus “Staph” aureus, or MRSA.
JNJ-Q2 Product Profile
JNJ-Q2 is a novel, broad-spectrum fluoroquinolone antibiotic that is Phase III-ready for two indications: ABSSSI and CABP. JNJ-Q2 has a low propensity to cause drug-resistance in vitro compared with other quinolones and has potent activity against two important drug-resistant pathogens: MRSA and drug-resistant Streptococcus pneumonia. In addition, JNJ-Q2 is highly active against other common and difficult to treat bacteria, including those that are gram-positive, atypical and anaerobic, as well as some gram negative bacteria. This broad bactericidal spectrum gives JNJ-Q2 an advantage over many other antibiotics, which do not reliably treat polymicrobial skin and wound infections or such a wide variety of respiratory pathogens. JNJ-Q2 is active against resistant pathogens that might be used in bioterrorism and also against ciprofloxacin-resistant gonorrhea. It showed excellent lung penetration in a pharmacokinetic study of healthy volunteers , and can be dosed both intravenously and orally, differentiating it from many other MRSA treatments that are only dosed intravenously.
In recognition of this unmet need, JNJ-Q2 was Granted Fast Track and Qualified Infectious Disease Product (QIDP) designations by the FDA in 2013. These designations should facilitate the use of certain incentives for the development of new antibiotics, including priority review and additional five-year market exclusivity, as provided under the Generating Antibiotic Incentives Now (GAIN) Act, which is incorporated within the FDA Safety and Innovation Act of 2012.
Clinical Development of JNJ-Q2 for Skin and Lung Infections
JNJ-Q2 demonstrated efficacy and favorable tolerability in a phase II double-blind randomized proof-of-concept study of for acute bacterial skin and skin-structure infections, where it was dosed orally, twice a day (link to publication by Covington,Anti Microb Agents &chemo, 2011 paper). It has also shown promise in a small “IV to oral switch” study of patients hospitalized for severe community acquired bacterial pneumonia .
Furiex acquired exclusive license rights to develop and commercialize JNJ-Q2 from Janssen in 2011.
View a list of Janssen and Furiex publications.
Fluoroquinolone clinical trials can be accessed at www.clinicaltrials.gov.
The worldwide antibiotics market generated sales of $42 billion in 2009 representing 5 percent of the global pharmaceutical market. The fluoroquinolone class generated $7 billion in global sales. Despite availability of a broad range of treatment options, the growth in antibiotic resistance among potentially life-threating pathogens is creating an increased need for novel products and new classes of antibiotics. Hospital stays for MRSA infections have more than tripled after 2000 and increased nearly ten-fold after 1995, with a 30 percent increase occurring from 2004 to 2005 . Although MRSA had previously been a hospital-acquired pathogen, its incidence has been rising in the community, and it has become the most frequent cause of skin and soft tissue infections presenting to emergency departments in the United States . There are a limited number of antibiotics approved to treat MRSA, and their frequent usage has led to emergence of multi-drug resistant bacteria. Thus, there is significant unmet medical need for new antibiotics such as JNJ-Q2 that provide flexible (hospital and outpatient) treatment options for MRSA.
- New England Journal of Medicine. 2006; 355:666-674.