Innocoll AG Announces First Patient Dosed in the Cogenzia COACT-1 Phase 3 Study for the Treatment of Diabetic Foot Infection
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 demonstrates 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.
“DFIs are a serious concern for diabetics which can result in significant morbidity such as inpatient hospitalization, delayed healing and even amputation,” said Dr.
The COACT-1 Phase 3 study is one 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 second Phase 3 study, COACT-2, is expected to start later this year. Each study is expected to enroll approximately 500 patients between the ages of 18 and 85 in
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-test of clinical cure. 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
More information on the study will be posted at www.clinicaltrials.gov.
“Any statements in this press release about our future expectations, plans and prospects, including statements about the development of Cogenzia for the adjuvant treatment of diabetic foot infections, such as the timing, conduct and outcome of the COACT-1 and COACT-2 Phase 3 studies for Cogenzia and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “goal,” “may,” “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including statements about the clinical trials of Cogenzia. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the timing and costs involved in developing and commercializing our products and product candidates, the timing for results, the initiation, conduct and timing of clinical trials, delays in potential approvals by
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