Los Angeles CA – October 19, 2021 – Azora Therapeutics Inc., a biopharmaceutical company focused on developing treatments for serious inflammatory diseases, announced today that the first patient has been enrolled in trial HS01, a phase 1b multicenter, randomized, double-blind, placebo-controlled study of topical AT193 for the treatment of mild-to-moderate hidradenitis suppurativa (HS). The study is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of AT-193 and is expected to enroll 40 patients with mild-to-moderate HS at multiple sites in Australia.
Hidradenitis suppurativa (HS) is a debilitating, chronic autoinflammatory disease affecting the apocrine gland-bearing skin. HS typically manifests as painful inflammatory nodules in the armpits, breasts, groin, and buttocks. Sustained inflammation contributes to the formation of abscesses, fistulas, and sinus tracts. Disease can be progressive, ranging from mild to severe, and can span decades in duration. The pathology of HS is poorly understood but involves microbial dysbiosis and an autoinflammatory response. Patients with HS have significantly impaired quality of life due to physical and psychological discomfort associated with the disease. There are no FDA-approved medications for the treatment of mild-to-moderate HS.
“Patients with mild-to-moderate HS may have fewer nodules or abscesses, but they still cause considerable pain and have the potential to rupture and drain onto clothing. A treatment option for these patients, preferably a convenient topical therapy, is sorely needed” stated Dr. Martin Okun, Azora Clinical Advisor and HS expert who helped design the pivotal phase 3 trials of adalimumab (Humira®) for moderate-to-severe HS that resulted in the first and only FDA-approved product for the disease.