Ferrer Successfully Completes a Phase III Clinical Trial in Adult and Paediatric Patients with Impetigo
News Jun 10, 2013
Ferrer has announced that it has successfully completed a phase III clinical trial in adult and paediatric patients with impetigo involving Ozenoxacin formulated as a topical treatment for dermatological infectious conditions.
The study demonstrated the superiority of Ozenoxacin 1 per cent cream, applied topically bid for five days, versus placebo on both the clinical and bacteriological endpoints by end of therapy visit (day 6-7).
In addition, Ozenoxacin 1 per cent cream demonstrated a superior bacteriological cure compared to placebo as early as visit two (day 3-4).
The trial also demonstrated that Ozenoxacin 1 per cent cream is safe and very well tolerated in the adult and paediatric population, which confirms the results of an absorption, tolerance and safety study in juveniles aged two months and above announced previously.
The trial, conducted at 27 centers in the United States, South Africa, Germany, Romania and Ukraine, involved 465 adult and paediatric patients aged two years and older with a clinical diagnosis of bullous or non-bullous impetigo.
Ozenoxacin is a novel non-fluorinated quinolone antibacterial agent. 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 Fernando Garcia Alonso, chief scientific officer at Ferrer.
Alonso continued, "The emergence of treatment resistant bacterial pathogens underpins the need for alternative agents. The clinical studies 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. This study, along with a previously announced absorption, tolerability and safety trial in adult and juvenile patients with impetigo aged two months and over, may form the basis of a first regulatory filing for Ozenoxacin in 2015."
The product is available for licensing worldwide from Ferrer, except in China, Japan, Korea and Taiwan.