XOMA Corporation, a leader in the discovery and development of therapeutic antibodies, has opened enrollment in a pilot study to determine gevokizumab's potential to treat acute inflammatory pyoderma gangrenosum. Pyoderma gangrenosum (PG) is one of the several rare diseases that are classified under the broader cluster of neutrophilic dermatoses. XOMA's pilot study is designed to enroll up to eight patients who are experiencing acute inflammatory PG. An inflammatory episode of PG is characterized by recently developed active ulcers and ulcer-related pain.
"We had previously indicated that XOMA and our partner SERVIER would evaluate the potential to test gevokizumab in a couple of rare disease areas, neutrophilic dermatosis and Schnitzler syndrome. Since the majority of Schnitzler patients are in Western Europe, SERVIER has been actively exploring the potential to pursue this indication in this orphan disease while we have been working with the experts in the neutrophilic dermatosis field to identify which subset of this rare disease class might respond best to gevokizumab. They believe acute inflammatory pyoderma gangrenosum is an ideal candidate, as a significant number of the patients tend to have an underlying inflammatory disease that results in PG's hallmark skin lesions," stated John Varian, chief executive officer of XOMA. "We sought FDA's input on PG prior to deciding if this disease condition should be pursued. Our pilot study will help us understand gevokizumab's ability to treat these patients. With positive results from a small pilot study in PG, we believe we will be able to have a productive End of phase 2 meeting with FDA to finalize the design of a potential pivotal programme."
XOMA's pilot study is designed to enroll up to eight patients who are experiencing acute inflammatory PG. The study is designed to evaluate the response in the first four patients and be able to make decisions to continue the study with a higher dosing regimen. Patients will be assessed on Day 28 to determine gevokizumab's efficacy in controlling the acute inflammatory symptoms of PG, and on Day 84 to determine gevokizumab's longer-term effect on skin ulcers. Both investigator and patient global assessments will be evaluated throughout the study.
Pyoderma Gangrenosum (PG), an inflammatory disease, is one of the several rare diseases that are classified under the broader neutrophilic dermatosis indication. PG typically begins with the formation of sterile pustules that evolve into painful ulcers of varying sizes and depths. These episodes may be mild or malignant, chronic or relapsing, and they can be permanently disfiguring. Patients typically are treated with high-dose corticosteroids and immunosuppresants to stop the progression of the ulcers. The lesions can take several weeks to months to heal, leaving the patient at elevated risk for infection.
Annually, there are three to ten PG cases per one million people. The disease typically presents between the ages of 20 and 50, and there is a higher incidence in women. 50-70 per cent of the cases are associated with systemic diseases, particularly inflammatory bowel disease, ulcerative colitis or Crohn's disease, rheumatic arthritis, monoclonal gammopathy, and internal malignancy.
Gevokizumab is a potent monoclonal antibody with unique allosteric modulating properties and 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 that has been shown to be involved in non-infectious uveitis, including Behçet's uveitis, cardiovascular disease, and other auto-inflammatory diseases. By binding to IL-1 beta, gevokizumab inhibits the activation of the IL-1 receptor, thereby modulating the cellular signaling events that produce inflammation. Gevokizumab has been studied in over 500 patients, with approximately 300 patients on treatment for six months, and has been shown to be well-tolerated.
XOMA is a biotechnology company focused on advancing its portfolio of innovative therapeutic antibodies, both in late-stage clinical development and in preclinical research.
SERVIER is a privately run French research-based pharmaceutical company. Current therapeutic domains for SERVIER medicines are cardiovascular, metabolic, neurological, psychiatric and bone and joint diseases, as well as oncology.