US-based XOMA Corporation (XOMA) has received Orphan Drug Designation from the US Food and Drug Administration (FDA) for its IL-1 beta modulating antibody 'gevokizumab' for the treatment of pyoderma gangrenosum (PG).
Gevokizumab is a potent monoclonal antibody with an allosteric modulating properties and the potential to treat patients with a variety of inflammatory and other diseases.
It 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 diverse array of disease states, including non-infectious uveitis, cardiovascular disease and other auto-inflammatory diseases.
XOMA CEO John Varian said selecting pyoderma gangrenosum as the company's next Phase III indication reflects its commitment to creating and capturing value from gevokizumab, particularly in indications where patients have few effective treatment options.
"We intend to present what we believe are compelling data from our pilot study in PG and to solicit feedback from the FDA about the requirements for a Phase 3 program in this rare disease," Varian said.
Currently, gevokizumab is being evaluated in a global Phase III clinical program, termed EYEGUARD, which is being conducted by SERVIER and XOMA.
The trial is designed to determine gevokizumab's ability to treat acute non-anterior non-infectious uveitis (NIU) in EYEGUARD-A, to prevent disease flares in patients with Behcet's uveitis in EYEGUARD-B, and to prevent disease flares in NIU patients who are controlled with steroids and immunosuppressants in EYEGUARD-C.
