ATHLONE, Ireland - Innocoll AG (Nasdaq:INNL), a global, commercial-stage, specialty pharmaceutical company that develops, manufactures and supplies a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, today announced that the first patient was dosed in the COACT-2 (COgenzia Adjuvant for Complete Therapy) Phase 3 study for the treatment of diabetic foot infections (DFIs) using Cogenzia, Innocoll's topically applied, bioresorbable collagen sponge. COACT-2 is the second of two pivotal Phase 3 studies for Cogenzia to enroll the first subject. The study is being conducted in both the E.U. and the U.S.
Diabetic foot ulcers are a serious health concern and affect approximately 7% of diabetic patients each year. Up to approximately 58% of these ulcers may become infected. Published data demonstrate that the current standard of care for DFIs with systemic antibiotics has a 30-50% failure rate. Failure of treatment can lead to significantly increased risk of hospitalization and often to the need for amputation resulting in increased costs to the healthcare system and a much higher risk of mortality for patients. We believe Cogenzia has the potential to be the first topical antibiotic approved as adjuvant therapy for the treatment of DFIs and could significantly improve upon the current cure success rate.
Cogenzia acts in conjunction with systemic antibiotics and standard wound care to provide high concentrations of gentamicin directly to the site of DFIs. These concentrations are not normally possible with systemic gentamicin treatment due to the risk of side effects. In the Cogenzia Phase 2 program, data demonstrated a statistically significant improvement in the clinical cure rate when compared to systemic antibiotics and wound care alone. In the Phase 2 study, 100% of Cogenzia-treated subjects experienced a clinical cure compared to 70% for the control group.
"Foot infections are a serious problem for persons with diabetes, often leading to lower extremity amputation. It is critical we treat these infection with the most appropriate antibiotic therapy, covering the usual pathogens while avoiding unnecessary use of broad-spectrum antibiotics, to help avoid the development of bacterial resistance," said Dr. Benjamin A. Lipsky, Emeritus Professor of Medicine, University of Washington and Visiting Professor of Medicine, University of Geneva and University of Oxford. "The Cogenzia studies may help provide additional insight into the antimicrobial management of this potentially devastating infection and may enable a better understanding of the ideal treatment paradigm for this problem."
The COACT-2 Phase 3 study is the second of two identical randomized, placebo-controlled, blinded studies to investigate the safety and efficacy of a topical gentamicin-collagen sponge in combination with systemic antibiotic therapy in diabetic patients with an infected foot ulcer. The first Phase 3 study, COACT-1, started in May of this year. Each study is expected to enroll approximately 500 patients between the ages of 18 and 85 in the EU (COACT-2) and United States (COACT-1 and 2). Patients diagnosed with moderate to severe DFIs will be treated in one of three arms per study: a Cogenzia sponge, a placebo sponge or no sponge with all patients in the study receiving systemic antibiotics and standard would care.
The primary endpoint is treatment effectiveness, test of clinical cure, which will be evaluated by the investigator at the post-treatment visit scheduled approximately 10 days post completion of treatment. Safety will be evaluated through the collection of adverse events through 90 days post completion of treatment. Additional key secondary endpoints include the percentage of patients with complete eradication of the pathogen, time to clinical cure, percentage of patients with an amputation and percentage with ulcer closure.
To qualify for the study, patients must have diabetes mellitus, according to the American Diabetes Association (ADA) criteria and have at least one skin ulcer located on or below the ankle that presents as a moderate or severe infection based on the Infectious Disease Society of America guidelines for the "Diagnosis and Treatment of Diabetic Foot Infections" (CID 2012; 54:132-173). Following screening and determination of eligibility, study participants will be assigned to one of three groups. Patients will be treated with daily sponge / dressing changes and systemic antibiotics for up to 28 days and the evaluation of clinical cure will occur 10 days thereafter. Topline results from the study are expected in the middle of 2016.
More information on the study will be posted at www.clinicaltrials.gov.
About Innocoll AG
Innocoll is a global, commercial-stage, specialty pharmaceutical company. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies. The company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColl® for the treatment of post-operative pain; Cogenzia® for the adjuvant treatment of diabetic foot infections; and CollaGUARD®, a barrier for the prevention of post-surgical adhesions. The Company's approved products include: CollaGUARD(Ex-US), Collatamp® G, Septocoll®, RegenePro®, Collieva®, CollaCare®, Collexa®, and Zorpreva™, which are sold through strategic partnerships with various partners including Takeda, Biomet, and EUSA Pharma. All of the company's products and product candidates are made using Type 1 collagen and are manufactured in-house at its facility in Saal, Germany. CollaRx®, Collatamp®, CollaGUARD®, Collieva®, CollaCare®, Collexa®, Cogenzia® LidoColl®, LiquiColl®, Septocoll®, and XaraColl® are registered trademarks, and CollaPress™, DermaSil™, Durieva™, and Zorpreva™ are trademarks of the company.