Spanish drugmaker Ferrer has initiated Phase III studies for its investigational antibacterial ozenoxacin as a topical treatment for impetigo and other infectious skin conditions.
The Barcelona-headquartered group says the trials for ozenoxacin, a second generation non-fluorinated quinolone, are scheduled to complete in the first quarter of 2013. About 465 patients up to two years old with impetigo will be recruited at 50 centres in the USA, South Africa, Germany, Romania, India and the Ukraine.
Ferrer noted that Phase I and II trials involving 1,000 subjects have demonstrated topically-formulated ozenoxacin is both efficacious, safe and well tolerated. Impetigo is highly contagious and is most commonly found amongst infants involved in close contact sports or living in enclosed environments. The condition usually manifests itself as blisters or sores on the face, neck, hands and trunk.
Ferrer obtained exclusive worldwide rights to ozenoxacin (except China, Japan & Taiwan) from Japan's Toyama and says the product is available for licensing worldwide from Ferrer, except in China, Japan and Taiwan. The drug is also being assessed in a variety of indications, such as bone and joint, plus pulmonary infections.