Ferrer successfully completes an absorption, tolerability and safety study in juveniles for Ozenoxacin
Ferrer announced that it has successfully completed an absorption, tolerability and safety clinical trial in adult and juvenile patients from two months of age with impetigo involving Ozenoxacin formulated as a topical treatment for infectious dermatological conditions.
The study, conducted at two centres in South Africa and involving 46 patients, demonstrated that topical Ozenoxacin was safe and well tolerated in adults and juveniles aged 2 months - 18 years old, with no significant evidence for systemic exposure.
This study will form the basis of a first regulatory filing for Ozenoxacin in 2013, along with an on-going multicentre, randomised, placebo controlled, parallel, double-blinded, superiority clinical study, comparing Ozenoxacin one per cent cream versus placebo involving about 465 patients more than two years old (there are now over 360 patients enrolled) with a clinical diagnosis of non-bullous or bullous impetigo. This study is being conducted at approximately 50 centers in the USA, South Africa, Germany, Romania and the Ukraine and is scheduled to complete in the first quarter, 2013.
Ozenoxacin is a non-fluorinated quinolone antibacterial agent undergoing clinical development. The agent has been 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. Importantly, given the maturity of other products in this field, these include clinical isolates of organisms with emerging resistance to quinolones and other commonly prescribed topical antibiotics.
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