Aristea Therapeutics Announces Dosing of First Patient in Phase 2b Trial of RIST4721 in Palmoplantar Pustulosis

Aristea Therapeutics (Aristea), a clinical-stage immunology focused drug development company advancing novel therapies to treat serious inflammatory diseases, today announced the dosing of the first patient in its Phase 2b trial evaluating RIST4721, a CXCR2 antagonist, for the treatment of palmoplantar pustulosis (PPP), a rare inflammatory skin disorder.

“This is a promising time in the company’s progress, and we are glad to have commenced our Phase 2b trial of RIST4721 in PPP,” stated James M. Mackay, Ph.D., President and CEO of Aristea. “This is a condition with no approved therapies in the United States or Europe, and we are excited to keep moving forward in developing a potential treatment option for these patients in need.”

PPP is a rare chronic inflammatory skin condition characterized by the recurrent appearance of sterile pustules filled with neutrophils on the palms of the hands and soles of the feet. Patients with PPP suffer from inflammation and cracking of the skin, causing pain, bleeding, itching and burning. This disease makes the performance of daily tasks extremely difficult and patients have dramatic challenges to their quality of life. There are no approved therapies in the United States or Europe, and those suffering from PPP have limited therapeutic options. PPP is a rare condition and most commonly seen among women ages 40-69 and those with a history of smoking tobacco.

RIST4721-202 is a randomized, double-blind, placebo-controlled, Phase 2b, 12-week, dose-ranging study of RIST4721, a CXCR2 antagonist, in subjects with moderate to severe palmoplantar pustulosis. This trial is currently recruiting patients within North America (clinicaltrials.gov NCT05194839).

“Our Phase 2a trial demonstrated that RIST4721 is well tolerated in subjects with moderate to severe PPP over 28 days and may represent an effective treatment option,” commented Dr. Nihar Bhakta, Aristea’s Chief Medical Officer. “The Phase 2b, with a longer treatment duration and a larger pool of subjects, will help us move closer to bringing this potential therapy to those suffering from this burdensome condition.”

Aristea has Phase 2a studies in development for RIST4721 in four additional CXCR2-mediated diseases: familial Mediterranean fever, Behcet’s disease, hidradenitis suppurativa, and inflammatory bowel disease.