Corgentech, AlgoRx complete enrollment for phase 1/2 trial of Avrina for Eczema

By Angela McDaniels

Seattle, Dec. 6 - Corgentech Inc. and AlgoRx Pharmaceuticals Inc. said enrollment has been completed for the second of two phase 1/2 clinical trials of Avrina, Corgentech's drug candidate for the treatment of atopic dermatitis, a chronic skin disease also known as eczema.

The multi-center, randomized, double-blind, placebo-controlled trial, being conducted in Australia and Switzerland, will evaluate the safety and tolerability of once-a-day versus twice-a-day applications of Avrina to the skin of adult patients with mild-to-moderate eczema.

Roughly 120 patients will apply the study drug for 28 days to targeted areas of the skin and will be followed for 14 days after the final treatment. Periodic physician assessments of the targeted areas will be made to measure the degree of symptom severity as well as patient evaluations of itchiness, the companies said.

The first trial, being conducted at multiple sites in the United States, enrolled about 75 patients who were randomized in parallel to one of three active treatment dose groups or a control group. Patients applied the study drug twice daily for 21 days to targeted areas of the skin and are being followed for 28 days after the final treatment.

The companies said they expect to report data for both trials in the first quarter of 2006.

Characterized by itchiness, redness and thickening of the skin, eczema affects about 15 million people in the United States and is often associated with elevated levels of immunoglobulin E and a personal or family history of allergies, allergic rhinitis and asthma.

While topical corticosteroids are used to treat eczema, their chronic use is limited due to the potential for significant side effects. Topical calcineurin inhibitors have also shown potential in the treatment of this disease; however, these potent immunosuppressive agents have yet to produce long-term safety data, the companies said.

Avrina is a highly selective and potent inhibitor of the transcription factor, NF-kappaB, which is implicated in inflammatory diseases such as eczema, asthma and inflammatory bowel disease.

In preclinical studies, Avrina was efficiently delivered to intact skin using several easy-to-manufacture, inexpensive formulations and was effective in reducing the swelling and inflammation associated with eczema with minimal side effects, the companies said.

Corgentech is a biopharmaceutical company based in South San Francisco, Calif., that develops novel therapeutics for significant unmet medical needs.

AlgoRx is a private, emerging pharmaceutical company based in Secaucus, N.J., that develops pharmaceutical product candidates to address pain.

The two companies said they have signed a definitive agreement to merge and create a late-stage company that will be focused on developing and commercializing products for pain management and inflammation.

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