Novexatin^® successfully completed phase I clinical evaluation in 2009 in a study in which safety and tolerability of the drug were confirmed in 12 fungal nail infection patients. Importantly, no Novexatin^® was detected in the bloodstream of any of the patients dosed during the course of the study.

A placebo controlled, blinded, randomised, phase IIa clinical study was subsequently initiated and dosing completed in 2009. 48 onychomycosis patients dosed once-daily with Novexatin^® for 28 days were followed-up for 180 days after initiation of treatment. The data generated further demonstrated that Novexatin^® is safe and very well tolerated. Moreover this study also revealed the first evidence of efficacy for the product and demonstrated its ability to resolve nail infection after only 28 days of application. Patients reported improvement in nail appearance within days of beginning treatment.

A phase IIb study is planned for Q4/2011 and preparations for this are currently underway.

NovaBiotics aims to partner with/out-license Novexatin^® to an appropriate pharmaceutical entity for further clinical development of what the company believes is a world-beating, first-in-class therapeutic candidate and positive discussions with a number of parties are ongoing.