the first of two pivotal phase 3 clinical trial looking at the safety and efficacy of its orphan designated drug gevokizumab in patients with active pyoderma gangrenosum, a rare neutrophilic dermatosis of expanding necrotic skin ulcers, is open for patient enrollment.
The Phase 3 randomized, placebo-controlled study will enroll 58 patients with active pyoderma gangrenosum to receive gevokizumab 60 mg or placebo dosed subcutaneously once monthly (in addition to their current treatment regimen of low-dose corticosteroids and/or immunosuppressants). The primary endpoint is complete closure of the pyoderma gangrenosum target ulcer determined at Day 126 with confirmation a minimum of two weeks later at Day 140.
Pyoderma gangrenosum is a rare neutrophilic dermatosis of painful expanding necrotic skin ulcers. The exact number of patients with pyoderma gangrenosum is unknown but claims data estimate there are 11,000 - 14,000 people annually in the United States with the condition. Pyoderma gangrenosum is often associated with an underlying systemic condition, such as ulcerative colitis or Crohn's disease, but 30-50% of patients are idiopathic. Treatment of pyoderma gangrenosum consists mostly of managing the underlying cause (if known) and applying topicals to the ulcers.
XOMA plans to conduct two pivotal studies examining the efficacy and safety of gevokizumab studies in pyoderma gangrenosum. A pilot study by XOMA found that 5 of the 6 patients given gevokizumab responded to treatment and 4 patients experienced complete wound closure after 3 months.
Paul Rubin, MD, Senior Vice President, Research and Development and Chief Medical Officer at XOMA said:
"We believe gevokizumab has the potential to help PG (pyoderma gangrenosum) patients reduce the amount of time it takes to heal from this painful and unsightly condition. With the first U.S. only study open for enrollment, we will complete the necessary steps to open the second pivotal PG Phase 3 study, which will include both U.S. sites and centers outside of the United States."
Gevokizumab is a potent monoclonal antibody with unique allosteric modulating properties and has the potential to treat patients with a wide variety of inflammatory and other diseases. Gevokizumab binds strongly to interleukin-1 beta (IL-1 beta), a pro-inflammatory cytokine, and modulates the cellular signaling events that produce inflammation. IL-1 beta has been shown to be involved in a diverse array of disease states, including Behçet's disease uveitis, non-infectious uveitis, cardiovascular disease, and other auto-inflammatory diseases. Gevokizumab currently is being studied in multiple indications, including three global Phase 3 clinical programs in Behçet's disease uveitis, non-infectious uveitis and pyoderma gangrenosum.
Image of pyoderma gangrenosum courtesy of wikimedia commons