XBiotech starts antibody study for treating pyoderma gangrenosum

XBiotech has begun a phase 2 study based on anti-interleukin-1 alpha therapeutic antibody for treating patients with pyoderma gangrenosum.

Pyoderma gangrenosum (PG) is a rare, inflammatory skin disorder that affects about one in 100,000 people, according to a press release. It causes tissue necrosis, which can result in severe, painful ulcers, usually on the legs. In half the cases, PG is a secondary disease to an underlying ailment including inflammatory bowel disease, systemic arthritis, hematological diseases and malignancies, the release said.

The study is based on efficacy of anti-IL-1 alpha (IL-1a) therapy in previous studies of psoriasis and acne, according to XBiotech. Although PG’s exact pathogenesis is unclear, an altered innate immune response is believed to be responsible. Treatments have included wound dressings, corticosteroids and immunosuppressant drugs

“IL-1a is a key cytokine that drives sterile inflammation, in particular wound-healing responses, and is also present in keratinocytes where it is thought to stimulate and propagate inflammation in response to tissue damage,” the release said. “IL-1a is therefore expected to play a key role in the pathogenesis of inflammatory dermatoses, such as PG.”

“While pyoderma gangrenosum is fascinating to most dermatologists, managing these patients can be quite challenging,” Armand Cognetta, MD — an investigator in Florida State University’s division of dermatology where the study will be conducted — said in the release. “We believe that anti-IL-1a therapy may ultimately serve as a safe and effective alternative to corticosteroids and infliximab in these patients.”

XBiotech said it expects the FDA to consider PG an orphan indication, allowing expedited clinical development.