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news.Innocoll Technologies has said that a special protocol assessment (SPA) has been submitted for a proposed Phase 3 clinical trial to support the US approval of Cogenzia.
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Cogenzia is Innocoll’s topical antibiotic therapy for the adjuvant treatment of infected diabetic foot ulcers.
Patients with a moderate or severe diabetic foot infection will be treated in the planned randomised, placebo-controlled, double-blind Phase 3 clinical trial, 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.
In the trial, the patients are expected to 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.
According to Innocoll, in the Phase 2 study, 100% of Cogenzia-treated patients who completed the study achieved clinical cure, which was statistically superior to 70% of patients in the control group. Patients in the Cogenzia group also had a higher rate of baseline pathogen eradication and a reduced time to pathogen eradication.
Innocoll said that the Phase 3 study design is based on positive Phase 2 data.
Michael Myers, president and CEO of Innocoll, said: “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.”