XOMA begins Phase III trial of gevokizumab to treat active ulcers in PG patients

The trial is designed to evaluate the efficacy and safety of gevokizumab in treating the active ulcers caused by this disease.

In February 2014, the US Food and Drug Administration (FDA) granted orphan drug designation to gevokizumab for PG.

XOMA chief medical officer and senior vice-president of Research and Development Paul Rubin said: "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.

"Patients with PG experience deep and painful skin ulcers that often become chronic wounds. In our pilot study, five of the six patients enrolled responded to gevokizumab, and four experienced complete wound closure by three months.

"We believe gevokizumab has the potential to help PG patients reduce the amount of time it takes to heal from this painful and unsightly condition.

"With the first US only study open for enrollment, we will complete the necessary steps to open the second pivotal PG Phase 3 study, which will include both US sites and centers outside of the US."

A total of 58 patients with active PG will be enrolled in the randomized, placebo-controlled Phase III trial.

During the trial, patients will be given gevokizumab 60mg or placebo dosed subcutaneously once monthly, in addition to their current treatment regimen of low-dose corticosteroids and/or immunosuppressants.

The trial’s primary endpoint is complete closure of the PG target ulcer determined at Day 126 with confirmation a minimum of two weeks later at Day 140.