Aristea Therapeutics Announces Dosing of First Patient in Open-Label Extension for Phase 2b Trial of RIST4721 in Palmoplantar PustulosisJune 30, 2022
SAN DIEGO, June 30, 2022 /PRNewswire/ — Aristea Therapeutics (Aristea), a clinical-stage immunology focused drug development company advancing novel therapies to treat serious inflammatory diseases, today announced it has dosed its first subject in the open-label extension (OLE) for its Phase 2b trial of RIST4721 in palmoplantar pustulosis (PPP), a rare dermatological condition.
“This brings us another step forward in the development of a potential treatment for this burdensome disease,” commented James M. Mackay, Ph.D., President and CEO of Aristea. “PPP has no approved therapies in the US or Europe and there is a significant unmet medical need for these patients. The OLE of our Phase 2b clinical trial will allow us to collect additional long-term safety and efficacy data that will help us further characterize the potential for RIST4721 in patients with PPP”
PPP is is characterized by the recurrent appearance of sterile pustules filled with neutrophils on the palms of the hands and soles of the feet. It poses dramatic challenges to quality of life and the performance of daily tasks for patients suffering from PPP.
The Phase 2b trial, 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. A previously completed Phase 2a trial demonstrated that RIST4721 is well tolerated in subjects with moderate to severe PPP and may represent an effective treatment option for this condition.
The OLE portion of RIST4721-202 is open to all PPP patients that have successfully completed the 12 week double blind portion of RIST4721-202 Phase 2b study. All subjects entering the OLE portion of the study will receive RIST4721 400mg and treatment is planned for 72 weeks plus a 4 week follow-up.
About Aristea Therapeutics
Aristea Therapeutics (Air-iss-tay-uh) is a clinical-stage immunology focused drug development company developing novel therapies to treat serious inflammatory diseases. The Aristea team is leveraging its broad industry expertise and proven success in drug development to form synergistic partnerships and build a pipeline of novel drugs. Aristea’s lead program, RIST4721, is currently in Phase 2b clinical development. Aristea is headquartered in San Diego, CA.
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