
In 2013, Ferrer successfully completed the first Phase 3 clinical trial of Ozenoxacin in adult and pediatric patients with impetigo. The study demonstrated the superiority of Ozenoxacin, applied topically twice daily for five days, versus placebo on both the clinical and bacteriological endpoints by the end of therapy. In addition, Ozenoxacin demonstrated a superior bacteriological cure compared to placebo, typically by day four. Ozenoxacin was shown to be very well tolerated in both adult and pediatric populations. Development plans include an additional Phase 3 clinical trial.
In preclinical in vitro and in vivo studies, Ozenoxacin has shown excellent antibacterial activity against a broad range of bacteria, including organisms with emerging resistance to other commonly prescribed topical antibiotics.
“Impetigo due to bacterial skin infections is a common problem, especially in infants and young children,” said Fernando Garcia Alonso, chief scientific officer at Ferrer. “The emergence of treatment-resistant bacterial pathogens underpins the need for alternative agents, such as Ozenoxacin. The clinical studies performed by Ferrer with Ozenoxacin aim to provide patients with impetigo an alternative, safe and effective topical antibacterial treatment. In addition, Ozenoxacin could potentially represent a topical treatment for a broad range of other infectious dermatological conditions.”
“We are proud to partner with Ferrer to maximize the commercialization of Ozenoxacin in the United States,” said Bradley Glassman, chairman and chief executive officer of Medimetriks. “We are committed to investing in the future of dermatology, and ensuring that the Dermatology community and its patients have new ways to treat unmet medical needs. Ozenoxacin is an example of this commitment, and we expect our pace of investments in Dermatology to increase.”
Date: March 25, 2014
Source: Medimetriks Pharmaceuticals