Medimetriks Pharmaceuticals, Inc. Announces that the Second Phase III Study for Ozenoxacin has been Initiated by Ferrer
FAIRFIELD, N.J., June 12, 2014 /PRNewswire/ -- Medimetriks Pharmaceuticals, Inc. announced today that its licensor, Ferrer, has initiated the second Phase III clinical study for Ozenoxacin, a novel bactericidal non-fluorinated quinolone in development for impetigo. Ferrer, a privately-help Spanish pharmaceutical company, licensed US rights for Ozenoxacin to Medimetriks earlier this year.
The multicenter, randomized, double-blinded, clinical study compares Ozenoxacin 1% cream versus placebo. The study will be conducted in more than 400 patients 2 months and older with a clinical diagnosis of non-bullous or bullous impetigo at approximately 36 centers in the United States, South Africa, Germany, Spain, Romania, Russia and Puerto Rico, subject to completion of additional regulatory approvals. The study is expected to be completed in the first quarter of 2015. Further details will be available at http://www.clinicaltrials.gov.
In 2013, Ferrer successfully completed 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 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 4. Ozenoxacin was shown to be very well tolerated in both adult and pediatric populations.
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."
"Ozenoxacin is on track to complete its phase III study and eventual NDA filing," stated Bradley Glassman, Chairman & Chief Executive Officer of Medimetriks. "We are excited about the potential for Ozenoxacin to help Dermatologists and their patients with impetigo. We are committed to partnering with the Dermatology community to develop new treatments for unmet medical needs, and Ozenoxacin is an example of this commitment."
Impetigo is a highly contagious bacterial skin infection. It most commonly affects infants, young children and those involved in close contact sports or living in enclosed environments. In the United States, impetigo is estimated to account for approximately 10% of the skin problems observed in pediatric clinics. It is also considered the most common bacterial skin infection and third most common skin condition in children.
Ozenoxacin belongs to a new generation of non-fluorinated quinolones. It is undergoing clinical development, formulated as a topical 1% cream, for dermatological infections. The bactericidal action of Ozenoxacin has resulted in an excellent in vitro and in vivo antibacterial activity against a broad range of pathologically relevant bacteria, including methicillin resistant Staphylococcus aureus strains, and clinical isolates of organisms with emerging resistance to quinolones and other topical antibiotics.
Founded in 1959, Ferrer is a privately-held Spanish pharmaceutical company. It is present in more than 90 countries, with 27 international affiliates. Ferrer is active in the pharmaceutical, health, fine chemicals and food sectors, key areas for contributing to people's health and quality of life.
The main therapeutic areas covered by Ferrer's pharmaceutical production are dermatology, cardiovascular, CNS, cancer, gastrointestinal, analgesics, bone metabolism, anti-infective, immunology, diagnostics, OTC and dermocosmetics.
For more information, please visit: www.ferrer.com
About Medimetriks Pharmaceuticals, Inc.
Medimetriks Pharmaceuticals, Inc., founded in 2008 as a specialty pharmaceutical company, develops, licenses and commercializes prescription skincare products with a focus on Dermatology and select specialty markets. The Company's mission is to enhance patient quality-of-life by providing innovative therapies that advance patient care.
For more information, please visit: www.medimetriks.com.
Contact: David Addis
Senior Vice President, Brand Communication
Medimetriks Pharmaceuticals, Inc.
(973) 882-7512, ext. 569
SOURCE Medimetriks Pharmaceuticals, Inc.