Hospital and Critical Care Infections

Finafloxacin is a novel member of the fluoroquinolone class of antibiotics. It demonstrates the unique property of being activated under acidic conditions, where the activity of many existing antibiotics is impaired. Bacterial infections create local, acidic environments yet many marketed antibiotics are most effective at a neutral pH. Finafloxacin provides a unique opportunity to exceed the efficacy of gold standard treatments against a wide range of bacterial infections. The compound is currently in clinical development for treating serious bacterial infections in the hospital and critical care setting as an intravenous and oral therapy. 

Infections due to Community-associated MRSA

Infections due to community associated clones of MRSA(CA-MRSA) have reached epidemic proportions in many countries and now account for the majority of Staphylococcus aureus isolates in most parts of the USA.

Finafloxacin exhibits highly potent activity against a wide range of CA-MRSA isolates and a remarkably low potential to select for resistant variants. The acidic environments associated with such infections, particularly within abscesses or intracellular environments, should make finafloxacin an attractive choice for therapy.

Intraabdominal Infection (IAI)

IAI represents a wide array of serious hospital setting bacterial infections and will be the first focus of clinical investigation for the intravenous formulation of finafloxacin. In addition to the acidic environment that characterises these infections, the ability of finafloxacin to target intracellular dwelling bacteria and its extended potency against anaerobic species suggest that the compound could offer significant improvements over existing therapies.

Chronic Obstructive Pulmonary Disease (COPD)

As in CF, COPD creates conditions in the airways that predispose patients to chronic bacterial infection that can severely impact the quality of life.

Exacerbations of infection range from mild to severe. Finafloxacin, with its ability to act under harsh acidic conditions, should be well suited for treatment of these severe infections.

Chronic Infection of Cystic Fibrosis Patients

Cystic fibrosis (CF) is characterised by progressive, obstructive lung disease and chronic bacterial infection that begins early in life and is the cause of premature death in 90% of patients. Successful management of chronic infection and resultant exacerbations can improve the quality of life and extend the lifespan of CF patients, however this remains a significant treatment challenge. Chronic inflammation results in an acidification of the airways and creates microenvironments that promote formation of bacterial biofilms, further reducing the efficacy of existing antibiotics.

Finafloxacin represents a new generation of fluoroquinolone antibiotics, optimised to be more effective under clinically relevant environmental conditions. The compound works optimally at the pH of chronically inflamed airways, exhibits potent bactericidal activity against persistent and biofilm forms of bacterial growth and is active against a wide range of bacterial pathogens, including anaerobic species. Twinned with its excellent safety profile, finafloxacin could offer real therapeutic advantages over existing therapies for exacerbations of chronic CF infection and is currently being investigated as an oral therapy in patients with CF.

Other Hospital and Critical Care Infections

Additional clinical investigations will target complicated urinary tract infection (cUTI), complicated skin and skin structure infection (cSSSI) as well as diabetic foot and tuberculosis. All are infections which present significant treatment challenges, including difficult anatomical sites and environmental conditions for drug penetration, antibiotic resistance, biofilms, as well as intracellular and other persistent forms of bacterial growth. Finafloxacin, as a broad spectrum antibiotic that exhibits optimal potency and lowered potential for resistance development under infection-relevant conditions can be expected to offer real advantages in these indications.

Helicobacter pylori

H.pylori colonises the gastric mucosa causing lifelong chronic inflammation. This can result in a number of diseases, including chronic active, chronic persistent and atrophic gastritis in adults and children, as well as duodenal and gastric ulceration and is the most important risk factor for gastric cancer (the pathogen has been declared as a class I carcinogen by the WHO). Current therapies require combinations of 3 to 4 different drugs and are only about 70% effective. Finafloxacin has demonstrated clinical efficacy in eradicating H.pylori infection and could offer significant improvements over existing therapies in terms of simplicity, safety and effectiveness.