The pharmaceutical company Ferrer has received approval to start phase III human trials of ozenoxacin, formulated as a topical treatment for infectious skin conditions. In February 2012, participants are expected to enter the multicenter, randomized, placebo controlled, parallel, double-blinded superiority clinical study, which is scheduled to complete in 2013.
The study will consist of approximately 465 infants younger than 2 years old, with a clinical diagnosis of non-bullous or bullous impetigo, at around 50 centers in the USA, Germany, Romania, Ukraine, South African and India, subject to completion of additional regulatory approvals. Participants will receive either ozenoxacin 1% cream or placebo.
Ozenoxacin belongs to a new generation of non-fluorinated quinolone antibacterial agent. Ozenoxacin is currently undergoing clinical development, formulated as a topical 1% cream for infectious skin conditions.
In preclinical and clinical studies (Phase I and II, in around 1,000 subjects), the bactericidal action of the cream (through powerful dual inhibition of DNA gyrase and topoisomerase IV) has demonstrated excellent in vitro and in vivo antibacterial activity against a vast range of pathologically relevant bacteria, including clinical isolates of organisms with emerging resistance to quinolones, methicillin resistant strains of staphylococcus as well as other topical antibiotics.
Results from phase I and II trials, in adults with secondarily infected traumatic lesions (SITLs), revealed that ozenoxacin is safe, effective, and well tolerated. In addition, the researchers found no evidence of dermal absorption or side effects connected with topically formulated halogenated quinolones, such as photoallergic reactions, photoirritation reactions, or sensitization potential.
Ozenoxacin could represent a first-in-class treatment option for a variety of infectious skin conditions, including those due to streptococcus pyogenes and staphylococcus aureus, the most encountered pathological causes of impetigo.
In addition, ozenoxacin is being evaluated for potential development in a wide range of systemic indications, such as pulmonary infections and bone and joint infections.
Toyama granted Ferrer exclusive worldwide rights to ozenoxacin, expect for Taiwan, China and Japan. Ozenoxacin is available for licensing worldwide from Ferrer, except in China, Japan and Taiwan.
Ferrer is a privately-held, Spanish pharmaceutical company with full vertical integration from R&D to distribution.
Impetigo is common bacterial skin infection most often found among infants and young children, individuals living in enclosed environments and those involved in close contact sports. Although impetigo is highly contagious, it is not common in adults. Symptoms include, skin lesions on the face, arms, or legs, blisters filled with pus.
Bullous impetigo mainly affects children younger than 2 years old. It causes painless, fluid-filled blisters, usually on the arms, legs and trunk. The skin around the blister is usually red and itchy but not sore.
Non-bullous impetigo is more contagious and causes sores that leave a yellow-brown crust once ruptured.
Streptococcus and staphylococcus are the primary cause for both bullous and non-bullous impetigo.
Written by Grace Rattue