VANCOUVER, BC – Apr. 3, 2019
Ondine Biomedical Inc. (Ondine) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its fixed-dose combination product for the prevention of post-surgical staphylococcal infections. The same fixed-dose combination product was recently also designated as a Qualified Infectious Disease Product by the FDA.
Ondine’s nasal Photodisinfection system is a first-in-class, light-activated, non-antibiotic, antimicrobial therapy developed to eradicate a broad spectrum of nasal pathogens without promoting antibiotic resistance, including the ‘superbug’ methicillin-resistant Staphylococcus aureus (MRSA).
Fast Track expedites the development of new therapies which are intended to treat serious or life-threatening conditions with unmet medical needs. Fast Track is granted when, among other criteria, FDA determines that the therapy may show superior effectiveness on serious outcomes or avoids serious side effects while providing the ability to address emerging public health needs. The intended purpose of the Fast track program is to get important new therapies to patients earlier, including earlier and more frequent meetings with FDA, eligibility for accelerated approval, and access to rolling review (on-going NDA review versus one-time review after submission).
“Fast Track designation is a valuable and appreciated recognition by FDA that our nasal Photodisinfection system has the potential to significantly impact the prevention of post-surgical staphylococcal infections,” stated Dr. Roger Andersen, MD, Vice President, Regulatory and Clinical Affairs. “After many years of use in Canada, with tens of thousands of patients treated, hospitals using our nasal Photodisinfection system have experienced substantially reduced infection rates which translates to patients with fewer post-operative complications, reduced antibiotic usage, and reduced healthcare costs. We are committed to working closely with FDA to rapidly advance this development program in the US.”
About Post-Surgical Site Infections
Surgical site infections (SSI’s) account for 15% of all hospital acquired infections and contribute substantially to morbidity and mortality each year. Up to 5% of surgical patients will develop an SSI in hospital, often resulting from Staphylococcus aureus infection. In many cases this virulent pathogen exhibits multidrug resistance making it increasingly difficult to treat. The evolution of antimicrobial resistance stems from the widespread use of antibiotics as growth enhancers in animal feed, the inappropriate use in viral and non-susceptible infections, and the ease with which resistant microbes transfer between continents, cities, hospitals and patients. Existing approaches to eliminating nasal bacteria rely on expensive testing prior to surgery and/or prolonged antibiotic therapies. Compliance with these approaches is often poor, and the development of antibiotic resistance is a very real threat.
About Ondine Biomedical Inc.
Ondine Biomedical Inc. is dedicated to the development of non-antibiotic, anti-infective therapies for a broad-spectrum of bacterial, viral and fungal infections. Ondine’s antimicrobial program utilizes a platform technology called Photodisinfection, a light-activated approach being developed to provide rapid antimicrobial efficacy and reduced risk of antibiotic resistance. Over 70 patents in 21 patent families have been granted or are pending covering various aspects of the technology. Ondine’s flagship nasal Photodisinfection system has been deployed in Canada for several years, and other applications of the Photodisinfection platform are under development, including Sinuwave (TM), a Photodisinfection product to treat chronic rhinosinusitis, and an endotracheal tube photodisinfection product designed to reduce the incidence of ventilator-associated pneumonia.
Ondine Biomedical Inc.
Angelika Vance, Director – Corporate Communications