The clinical study is a 28-day Phase II, open label trial of anti-IL-1α therapeutic antibody in subjects with Pyoderma Gangrenosum. The study is led by Principal Investigator Dr. Armand Cognetta at Florida State University Division of Dermatology. Primary endpoints of the study involve clinicians’ and patients’ Global Assessment at day 28 from baseline. Patients found to be responding to therapy, but who haven't yet experienced complete resolution of their lesion(s) after 28 days of therapy, may participate in up to 2 additional 28-day cycles.
PG (Pyoderma Gangrenosum) is an inflammatory skin disorder that causes tissue necrosis and results in severe, painful ulcers, most commonly on the legs. While PG is a rare condition (affecting approximately 1 in 100,00 persons), it is devastating to those afflicted. It is often secondary to underlying diseases such as inflammatory bowel disease, systemic arthritis, hematological diseases and malignancies.
The inflamed, ulcerated skin lesions characterized by PG are heavily infiltrated with neutrophils in the absence of infectious stimuli. While the exact pathogenesis of PG is unknown, an altered innate immune response is believed to play a role in the disease process. IL-1α 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. IL-1α is therefore expected to play a key role in the pathogenesis of inflammatory dermatoses, such as PG.