Ferrer successfully completes second phase III clinical trial in adult and paediatric patients with impetigo for antibacterial Ozenoxacin

04-Aug-2015 - Spain

Ferrer announces that it has successfully completed a second phase III clinical trial in adult and paediatric patients aged two months and older with impetigo, utilizing Ozenoxacin 1% cream as a topical treatment for dermatological infectious conditions.

The study demonstrated the superiority of Ozenoxacin 1% cream, applied topically twice daily for five days, versus placebo, on both the clinical and bacteriological endpoints by the end of therapy (day 6-7). In addition, Ozenoxacin 1% cream demonstrated superior bacteriological cure compared to placebo as early as visit two (day 3-4). Ozenoxacin 1% cream was shown to be safe and very well tolerated in the adult and paediatric population.

The trial was conducted at 44 centres in the United States, Puerto Rico, South Africa, Germany, Romania, Russia and Spain. It involved 412 adult and paediatric patients aged two months and older with a clinical diagnosis of bullous or non-bullous impetigo. The first regulatory filing is anticipated during Q1 2016 in Europe by Ferrer, in the United States by Medimetriks Pharmaceuticals, Inc. and in Canada by Cipher Pharmaceuticals Inc.

“Impetigo due to bacterial skin infections remains a common problem worldwide, especially in infants and young children living in warm, humid climates,” said Fernando Garcia Alonso, chief scientific officer at Ferrer. “The emergence of treatment resistant bacterial pathogens underpins the need for alternative agents. Ozenoxacin could represent a topical treatment for a broad range of other infectious dermatological conditions, with a combined global market value approaching €540 million ($600M) per annum.”

https://www.bionity.com/en/news/153912/ferrer-successfully-completes-second-phase-iii-clinical-trial-in-adult-and-paediatric-patients-with-impetigo-for-antibacterial-ozenoxacin.html