Paratek begins phase I trial of novel antibiotic

PTK 0796 is a novel, broad-spectrum antibiotic from the aminomethylcyclines (AMCs) antibiotic family, which has been shown to be highly effective in animal models at treating clinically prevalent infections caused by Gram-positive, Gram-negative, atypical and anaerobic bacteria, including those with multi-drug resistance.

The phase I study is designed to measure the safety and tolerability of an intravenous formulation of PTK 0796 in healthy subjects. A further trial of an oral version of the treatment is planned for 2006.

Stuart Levy, chief scientific officer of Paratek, said: “Bacterial infections in hospitals are becoming increasingly difficult to treat, in large part because of rising bacterial resistance. Newer agents that are active against newly emerging and multi-drug resistant infectious disease agents are urgently needed.”

Preclinical studies of PTK 0796 suggest it is effective against community-acquired methicillin-resistant Staphylococcus aureus (MRSA) and other pathogens, such as those that cause pneumonia.

The trial represents the company’s first human study and will be the first time a compound from the AMC class has entered clinical development. The trial, which will take place in the UK, is expected to last several months. The company then anticipates investigating the drug’s potential in hospitalized patients with serious, life-threatening infections.