MerLion Pharmaceuticals initiates Phase 1 clinical study of Finafloxacin, a novel 'pH activated' antibiotic

26th September 2007

MerLion Pharmaceuticals (MerLion) announces today that it has commenced Phase 1 clinical trials of the novel antibiotic, finafloxacin. This compound demonstrates a unique acid activated activity, which differentiates it from existing antibiotic therapies and opens up exciting new product opportunities.

Finafloxacin is a highly potent eradicator of Helicobacter pylori (H.pylori). H. pylori is a slow growing bacterium present in the gastric lining of approximately 50% of the human population, with even greater rates of infection in the elderly and in the emerging markets of Asia. It is a major causative factor in the development of gastric ulceration and is also linked to the development of many gastric cancers. H. pylori is the only bacterium designated as a class I carcinogen by the World Health Organisation.

Dr Tony Buss, CEO of MerLion, said “The impressive anti-bacterial activity and safety profile of finafloxacin adds a differentiated, broad spectrum development candidate to our clinical pipeline. Finafloxacin represents an important breakthrough for treating gastrointestinal and other complicated infections that respond poorly to existing therapies.”

Current treatments for H. pylori consist of complex combinations of multiple antibiotics and acid lowering agents. These therapies are hampered by sideeffects, drug resistance and the risks of interactions with other drugs. Any reduction in the complexity of this therapy would represent a major step forward in the eradication of this organism and of other complex infections.

Dr Harald Labischinski, CSO of MerLion said “We are excited about bringing into the clinic a novel, causal antibiotic therapy targeted against the many conditions with prevailing acidic conditions at the site of infection. In addition to treatment of peptic ulcers and functional dyspepsia, the prospect also exists of preventing gastric cancers caused by life-long chronic infection with Helicobacter.”

Contact: Mr. Chris Molloy, Chief Operating Officer
Tel: +65 6829 5600
E-mail:
Visit MerLion's new website: http://www.merlionpharma.com

For Editors
Established bacterial infections themselves create, and adapt to, a locally acidic environment. This acidity coincidentally provides the organisms with partial protection from many marketed antibiotics, which are developed to function optimally at near-neutral pH and whose activity declines dramatically under even mildly acidic conditions. Finafloxacin overcomes this chemical barrier by becoming increasingly active under acidic conditions.

Web resources

Helicobacter pylori
http://www.helico.com/
http://www.hpylori.com.au/press/
http://www.cdd.com.au/html/expertise/diseaseinfo/helicobacter.html

About MerLion Pharmaceuticals Pte Ltd

MerLion Pharmaceuticals is a privately held international drug discovery and development company headquartered in Singapore. The company focuses internal R&D efforts on anti-infectives and maintains a leadership position in natural products drug discovery.

MerLion has a balanced portfolio of assets that includes clinical stage antibiotic candidates, a unique patent position in the area of bacterial virulence, innovative screening approaches and access to the proprietary discovery technologies of its many risk-share partners.

MerLion was recently identified by Fierce Biotech, a leading industry journal, as one of the world's most promising biotechnology companies.