Absorption, Tolerability and Safety Study for Novel Antibacterial Compound Completed
News Oct 19, 2012
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 novel 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.
"Impetigo due to bacterial skin infections remains a common problem worldwide, especially in infants and young children living in warm, humid climates," said Antonio Guglietta, R&D director at Ferrer. "The emergence of treatment resistant bacterial pathogens underpins the need for alternative agents. Clinical studies being performed by Ferrer with Ozenoxacin aim to provide infants and others with impetigo an alternative, safe and effective, topical antibacterial treatment. In addition, Ozenoxacin could represent a topical treatment for a broad range of other infectious dermatological conditions, with a combined market value approaching USD 800 million per annum."
Ferrer obtained exclusive worldwide rights to Ozenoxacin (except China, Japan, Korea and 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, Korea and Taiwan.