Finafloxacin
(Helicobacter pylori and UTI)

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 most marketed antibiotics are designed to be 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 targeted as a breakthrough therapy for Helicobacter pylori (H. pylori)eradication and for the improved treatment of urinary tract infections (UTI).

Helicobacter pylori

H. pylori is a Gram-negative spiral organism which colonises the gastric mucosa causing chronic gastritis. H. pylori causes chronic active, chronic persistent, and atrophic gastritis in adults and children. H. pylori -associated gastritis is present in almost all adults and children with duodenal and gastric ulceration. H. pylori causes lifelong chronic inflammation and spontaneous recovery is extremely rare yet eradication of H. pylori from the gastric mucosa results in long-term healing of duodenal ulcers. Chronic infection, even asymptomatic is the most important risk factor for gastric cancer and the pathogen has been declared as a class I carcinogen by the WHO. Studies have shown that the recurrence rate of peptic ulcers after one year is 2% or less in patients in whom the organism has been eradicated.

Finafloxacin represents a novel potential monotherapy for the eradication of Helicobacter pylori.

The global market for H. pylori eradication therapies is poorly understood. The current approved therapies are aggressive, complex combinations of proton pump inhibitors, such as omeprazole, and a variety of at least two oral antibiotics such as clarythromicin, amoxicillin and metronidazole.

In the absence of an effective mono (or dual) therapy for H. pylori eradication clinical guidelines currently recommend the use of non-branded medicines. Despite this it is clear that branded combinations of these generic drugs are also regularly prescribed. Sales of these branded products, which do not represent breakthroughs in treatment, represent a small yet visible fraction of the true number of patients under H. pylori eradication therapy. This fraction alone represents an annual market in the US of $ 170M.