Ferrer Initiates Phase III Clinical Studies for Ozenoxacin

Ferrer has announced that it has received approval to initiate phase III clinical trials of ozenoxacin formulated as a topical treatment for infectious dermatological conditions.

The first patients are expected to enter the trials in February 2012 and the studies are scheduled to complete in the first quarter, 2013.

The multicenter, randomized, placebo controlled, parallel, double-blinded, superiority clinical study, comparing ozenoxacin one per cent cream versus placebo will be conducted in about 465 patients up to two years old with a clinical diagnosis of non-bullous or bullous impetigo at approximately 50 centres in the USA, South Africa, Germany, Romania, India and the Ukraine, subject to completion of additional regulatory approvals.

Ozenoxacin is a novel second generation non-fluorinated quinolone antibacterial agent undergoing clinical development, formulated as a topical one per cent cream, for infectious dermatological conditions.

In preclinical studies, the bactericidal action of ozenoxacin (via potent dual inhibition of DNA gyrase and topoisomerase IV) has been shown to confer an excellent in vitro and in vivo antibacterial activity against a broad range of pathologically relevant bacteria, including clinical isolates of organisms with emerging resistance to quinolones and other commonly prescribed topical antibiotics.

The clinical efficacy of topical ozenoxacin cream has been demonstrated in a phase II dose-finding study in adult patients with secondarily infected traumatic lesions (SITLs).

Topical ozenoxacin has proven to be safe and well tolerated in clinical trials involving almost 1,000 subjects, exhibiting no dermal absorption and no evidence of the adverse effects associated with topically formulated halogenated quinolones.

Ferrer obtained exclusive worldwide rights to ozenoxacin (except China, Japan & Taiwan) from Toyama. Ozenoxacin formulated as a one per cent topical cream is the subject of a number of granted and pending patent applications.

The product is available for licensing worldwide from Ferrer, except in China, Japan and Taiwan.