ASHBURN, Va., July 13 Innocoll, Inc. announced that its wholly-owned subsidiary, Innocoll Technologies Ltd., has submitted a Special Protocol Assessment (SPA) for a proposed phase 3 clinical trial to support the U.S. approval of Cogenzia(TM): Innocoll's topical antibiotic therapy for the adjuvant treatment of infected diabetic foot ulcers.
The protocol was developed following an End of Phase 2 meeting with FDA where the results of Innocoll's phase 2 clinical studies were presented and discussed. In the planned phase 3 randomized, placebo-controlled, double-blind clinical trial, patients with a moderate or severe diabetic foot infection will be treated with Cogenzia on a daily basis as an adjunct to standard-of-care, which includes systemic antibiotic therapy administered by the oral or intravenous route. Patients will be treated for a maximum of 28 days and the primary endpoint will be the percentage of patients who are clinically cured of infection 10 days after discontinuation of all antibiotic therapy. The study design is based on a highly encouraging phase 2 trial where 100% of Cogenzia-treated patients who completed the study achieved clinical cure, which was statistically significantly superior to 70% of patients in the control group (P = 0.024). Patients in the Cogenzia group also had a significantly higher rate of baseline pathogen eradication and a reduced time to pathogen eradication (P < 0.001).
Dr. Michael Myers, Innocoll's President and CEO commented, "Building on the strength of the phase II data, we continue to make great strides in the development of our lead product, Cogenzia. We are particularly encouraged by the fact that the product will be developed as adjuvant therapy for use in conjunction with systemic antibiotics, a milestone event for the treatment of this large and rapidly growing unmet medical need."
Diabetic Foot Ulcers Infections:
Diabetic foot ulcer (DFU) infections represent a large and growing market for Cogenzia. According to the American Diabetes Association there were 23.6 million diabetic patients in the U.S. in 2007 and 220 million patients globally. Of these patients, approximately 15% will develop a DFU and 50% of those patients will develop an infected DFU, representing an estimated 2 million patients. Infected DFUs are currently treated with systemic antibiotics. However, diabetic ulcers are often associated with limited perfusion due to vascular disease and ischemia thereby rendering systemically acting antibiotics ineffective. According to a meta-analysis of 18 randomized controlled trials evaluating different antibiotics in treatment of diabetic foot infections, the combined observed treatment failure rate of antibiotic treatments of DFU infections is 22.7%. Local antibiotic treatment adjunct to a systemic agent can potentially address the unmet need in infections in DFU by improving anti-bacterial efficacy at the wound site. There are currently no approved, topically applied antibiotics in the U.S. that are indicated for the treatment of infections in DFU.
Cogenzia is a biodegradable and fully resorbable Gentamicin-Collagen Sponge formulated and manufactured using Innocoll's proprietary collagen-based drug delivery technology, CollaRx. Upon application to an open wound the product releases gentamicin, a broad-spectrum, aminoglycoside antibiotic with a concentration-dependent mechanism of action, for local action at the wound site. This technology achieves a high concentration of drug at the target tissue, while maintaining low systemic levels well below the toxicity threshold.
About Innocoll, Inc.
Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx®, CollaFilm(TM), DermaSil(TM) and Liquicoll®. In addition to Cogenzia, Innocoll has a second product in Phase 3 development, CollaRx GENTAMICIN SURGICAL IMPLANT for which it has licensed US marketing rights to Baxter Healthcare, a division of Baxter International Inc (NYSE: BAX) . This product is approved for sale in over 50 countries in Europe, Latin America, Middle East, Africa and Asia. Other late stage pharmaceutical products in Innocoll's development pipeline include XaraColl(TM), CollaRx Bupivacaine Implant, for the management of post-operative pain and CollaGUARD®, a collagen membrane for the prevention of surgical adhesions. For more information, please visit www.innocollinc.com.
SOURCE Innocoll, Inc.