Experimental Pyoderma Gangrenosum Drug Could Impact Crohn’s, Colitis Patients

Experimental Pyoderma Gangrenosum Drug Could Impact Crohn’s, Colitis Patients
XOMA Corporation, a company dedicated to developing antibody-based therapeutics, has begun patient enrollment for a pivotal phase III study of gevokizumab for the treatment of active pyoderma gangrenous (PG), a rare neutrophilic dermatosis of expanding necrotic skin ulcers. The study is meant to evaluate the efficacy and safety of the compound in treating active ulcers that develop as a result of the rare and debilitating illness, which was granted the orphan drug designation status by the U.S. Food and Drug Administration last February. The company is seeking to enroll 58 patients suffering from active PG, to participate in the phase III randomized, placebo-controlled study and be administrated either with gevokizumab 60 mg once a moth or placebo, subcutaneously. The patients will continue with their treatment regimens of low-dose corticosteroids and/or immunosuppressants, as prescribed by their physicians. The researchers established as primary endpoint the complete closure of the PG target ulcer, verified at the 16th day and confirmed two weeks later, at the 140th day. "We have reached another important milestone in our gevokizumab development activities with the launch of the first of two pivotal gevokizumab studies in pyoderma gangrenosum, one of the indications under the neutrophilic dermatoses umbrella for which there are no available therapies approved by the FDA," said the senior vice-president of research and development and chief medical officer at XOMA, Paul Rubin, MD. Being a monoclonal antibody with specific allosteric modulating properties, Gevokizumab aims to treat several inflammatory diseases. It blocks the pro-inflammatory cytokine interleukin-1 beta (IL-1 beta), as well as modulates the cellular signaling events responsible for the
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