Absorption, Tolerability And Safety Study In Juveniles For Novel Antibacterial Compound Ozenoxacin Completed
Ferrer, a privately-held Spanish pharmaceutical company with full vertical integration from R&D to distribution, has 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 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.
Impetigo is a highly contagious bacterial skin infection. It is most commonly found amongst infants and young children living in hot, humid climates, and those involved in close contact sports or living in enclosed environments. It is not common in adults. In the USA, impetigo is estimated to account for approximately ten per cent of the skin problems observed in paediatric clinics. It is also considered the most common bacterial skin infection and third most common skin condition of children.
The condition usually manifests itself as blisters or sores on the face, neck, hands and trunk. Scratching may spread the lesions to other parts of the body and the infection is transmitted between individuals by direct contact with lesions, with nasal carriers or sharing of towels etc. There are two types of impetigo: bullous, which causes large, painless, fluid-filled blisters, and non-bullous (approximately 70 per cent of cases), which is more contagious than the former and causes sores that quickly rupture to leave a yellow-brown crust. Both the bullous and non-bullous forms of impetigo are primarily caused by Staphylococcus aureus, with Streptococcus pyogenes also commonly involved in the non-bullous form.
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. 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.
Ozenoxacin could represent a first-in-class non-fluorinated quinolone treatment option (best-in-class quinolone) for the topical treatment of a broad range of infectious dermatological conditions, including those due to Staphylococcus aureus and Streptococcus pyogenes, the most commonly encountered pathological causes of impetigo and other skin infections such as SITLs. The worldwide market for topical antibacterial products is approximately USD 800 million per annum.