Innocoll submits SPA for phase 3 clinical trial of Cogenzia for adjuvant treatment of infected diabetic foot ulcers

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™:  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 < 0.001).

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."