Date: 2013-06-05
Type of information: Initiation of preclinical development
phase: 3
Announcement: results
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.
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: impetigo
Therapeutic area: Infectious diseases - Dermatological diseases
Country: USA, South Africa, Germany, Romania, India and the Ukraine
Trial details:
Latest
news: * On June 5, 2013, Ferrer, a privately-held Spanish pharmaceutical company, 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. Ferrer has indicated that this study 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.
* On January 19, 2012, 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.
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.
