Date: 2014-06-12
Type of information: Initiation of patient enrollment
phase: 3
Announcement: recruitment of the first patient
Company: Ferrer (Spain)
Product: ozenoxacin
Action
mechanism: Ozenoxacin belongs to a new generation of non-fluorinated quinolones. It is undergoing clinical development, formulated as a topical one per cent cream, for infectious dermatological conditions. Ozenoxacin acts via potent dual inhibition of DNA gyrase and topoisomerase IV. The bactericidal action of ozenoxacin has resulted in an excellent in vitro and in vivo antibacterial activity against a broad range of pathologically relevant bacteria, including against Methicillin resistant strains of Staphylococcus aureus and clinical isolates of organisms with emerging resistance to quinolones and other topical antibiotics. Ferrer obtained exclusive worldwide rights (except China, Japan, Korea and Taiwan) to Ozenoxacin from Toyama.
The clinical efficacy of topical ozenoxacin cream has previously been demonstrated in a phase II dose-finding study in adult patients with secondarily infected traumatic lesions (SITLs). Extensive preclinical and clinical studies (Phase I & II, in around 1,000 subjects) have demonstrated topically formulated ozenoxacin is safe and well tolerated, exhibiting no dermal absorption and no evidence of the adverse effects associated with topically formulated halogenated quinolones, such as photoirritation reactions, sensitization potential or photoallergic reactions.
Disease: adult and paediatric patients with impetigo
Therapeutic area: Infectious diseases - Dermatological diseases
Country:
Trial details:
Latest
news: * On June 12, 2014, Ferrer, a privately-held Spanish pharmaceutical company, announced that the first patient has been recruited into a second phase III trial of Ozenoxacin, formulated as a topical treatment for infectious dermatological conditions in adult and paediatric patients with impetigo. The study is scheduled to complete in Q1, 2015.
The multicenter, randomised, double-blinded, clinical study comparing Ozenoxacin one per cent cream versus placebo will be conducted in about 412 patients aged two months and over with a clinical diagnosis of non-bullous or bullous impetigo at approximately 36 centres in the USA, South Africa, Germany, Spain, Romania, Russia and Puerto Rico, subject to completion of additional regulatory approvals (further details will be made available at http://www.clinicaltrials.gov).
In 2013, Ferrer successfully completed a first phase III clinical trial of Ozenoxacin in adult and paediatric patients aged two years and over with impetigo. The study demonstrated the superiority of Ozenoxacin one per cent cream versus a placebo, applied topically twice daily for five days, on both the clinical and bacteriological endpoints by end of therapy visit. In addition, Ozenoxacin demonstrated a superior bacteriological cure compared to placebo by the second visit (day three-four). The trial also demonstrated that Ozenoxacin is safe and very well tolerated in the adult and paediatric populations.
“Impetigo due to bacterial skin infections remains a common problem, especially in infants and young children,” said Fernando Garcia Alonso, chief scientific officer at Ferrer. “The emergence of treatment resistant bacterial pathogens underpins the need for alternative agents such as Ozenoxacin. The clinical studies with Ozenoxacin performed by Ferrer 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.”
The product is available for licensing worldwide from Ferrer, except in China, Japan, Korea, Taiwan, USA, Puerto Rico and US Virgin Islands.
