Cogenzia®
There were 23.6 million diabetic patients in the US 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. Diabetic Foot Infections 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 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 DFI infections is 22.7%.
Diabetic foot is the most common cause of nontraumatic lower extremity amputations in the US and Europe, with an average of 82,000 amputations per year in the US costing an estimated $1.6 billion annually. The estimated cost of foot ulcer care in the US ranges from $4,595 per ulcer episode to more than $28,000 and the total annual cost of foot ulcer care in the US has been estimated to be as high as $5 billion.
Local antibiotic treatment adjunct to a systemic agent can potentially address the unmet need in DFI's by improving anti-bacterial efficacy at the wound site. There are currently no approved, topically applied antibiotics in the US that are indicated for the treatment of DFI.
Cogenzia® CollaRx Gentamicin Topical is in phase III development for the adjuvant treatment of infections in Diabetic Foot Ulcers. The product is a biodegradable and fully bioresorbable matrix of purified fibrillar collagen impregnated with gentamicin, and is designed to deliver high local concentrations of gentamicin directly to the wound site while maintaining systemic levels below the toxicity threshold. In a recent phase II Study, Cogenzia, as adjunct to systemic antibiotic, showed superior efficacy (100%) over systemic therapy alone (70%) with statistically significant clinical cure at 2 weeks post continuation of therapy (study completion). Based on the positive outcome of the phase II Study and recent end of phase II meeting with FDA, Innocoll will advance into phase III Clinical Trials under an SPA.