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Ferrer completes second Phase III trial of impetigo treatment ozenoxacin

Canada-based Cipher Pharmaceuticals' partner Ferrer International has completed the second Phase III clinical trial for ozenoxacin, a topical treatment for adult and paediatric patients with impetigo, a highly contagious bacterial skin infection.

In January, Cipher acquired the Canadian commercialization rights to ozenoxacin from Ferrer, a Spanish pharmaceutical company.

A total of 412 adult and paediatric patients aged two months and older with a clinical diagnosis of bullous or non-bullous impetigo were included in the trial, which was conducted at 44 centres in the US, Puerto Rica, South Africa, Germany, Romania, Russia and Spain.

The trial involved ozenoxacin formulated as a topical treatment for dermatological infectious conditions in adults and peadiatric patients.

Data from this trial showed the superiority of ozenoxacin 1% cream, applied twice daily for five days, against placebo on both the clinical and bacteriological endpoints by the end of the therapy visit (day 6-7). It also showed superior bacteriological cure compared to placebo as early as visit 2 (day 3-4).

Cipher Pharmaceuticals president and CEO Shawn Patrick O’Brien said: "The successful completion of the second phase III trial for Ozenoxacin moves us one step closer to an alternative treatment for one of the most common bacterial skin infections in children worldwide, amidst the emergence of treatment resistant bacterial pathogens.

"We look forward to the regulatory submission to Health Canada anticipated for the first quarter of 2016."

The company said that ozenoxacin 1% cream was shown to be safe and very well tolerated in the adult and paediatric population.

Ferrer expects a first regulatory filing of ozenxacin in Europe in the first quarter of next year and expects their US license partner to file for US regulatory approval during the same period.