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news.Biopharmaceutical novel therapeutics developer Corgentech has filed an investigational new drug application with the FDA to begin a phaseI/II clinical trial of its drug candidate for the treatment of eczema.
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This is the first of two phase I/II trials to be initiated. The second trial will be conducted in Europe and is likely to be initiated in the first half of 2005 in a similar patient population.
The multi-center, dose-ranging trial will evaluate the safety and feasibility of repeated application of three concentrations of the drug candidate, NF-kB decoy, in adult patients with mild-to-moderate eczema.
NF-kB decoy is a highly selective and potent inhibitor of the transcription factor, NF-kB, which is implicated in inflammatory diseases, such as eczema and inflammatory bowel disease (IBD).
“We believe that based on our pre-clinical experiments, NF-kB decoy can be delivered efficiently into skin cells and could potentially show fast acting results and efficacy approaching that of currently available therapies but without the associated side effects,” said John McLaughlin, president and CEO of Corgentech.