Medimetriks Pharmaceuticals, Inc. has entered into a licensing agreement with Ferrer, a privately-held Spanish pharmaceutical company, for the commercialization rights to ozenoxacin 1% cream in the United States. Ozenoxacin is a novel, bactericidal non-fluorinated quinolone in development as a topical treatment for impetigo.
In 2013, Ferrer ompleted the first Phase III Clinical Trial of Ozenoxacin in adult and pediatric patients with impetigo. The study demonstrated the superiority of ozenoxacin, applied topically twice daily for 5 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 4. Studies showed Ozenoxacin was very well tolerated in both adult and pediatric populations. Development plans include an additional Phase III 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,” says 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."