Arthrosi Therapeutics, Inc., a clinical-stage biotechnology company, announced the completion of enrollment for its global Phase 2b clinical study of AR882 for the treatment of chronic gout. The study, which exceeded the initial target enrollment of 120 patients, is designed to evaluate the safety and efficacy of AR882, an effective and selective uricosuric agent, in chronic gout patients who meet ACR/EULAR gout classification.
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“We are pleased to see the completion of enrollment in our global Phase 2b clinical study of our leading compound, AR882. The study has exceeded our initial enrollment target despite the COVID-19 pandemic. This is a major milestone for the development of AR882 for chronic gout treatment,” said Arthrosi CEO Litain Yeh. “I thank the patients who enrolled in this study, the efforts of clinical investigators from the U.S., Australia, and Taiwan, and our clinical operations team who worked diligently to advance the study to this point. We look forward to providing a clinical update later this year.”
The Phase 2b randomized, double-blind, placebo-controlled, multicenter clinical study is designed to enroll approximately 120 gout patients to assess safety and efficacy of AR882 in three cohorts: 50 mg, 75 mg, or placebo. Study participants will receive treatment for up to three months to evaluate serum urate (sUA) reduction and safety. A total of 24 clinical sites have participated. As of August 15, 2022, 92 patients and 75 patients have passed the six-week and three-month dosing milestones respectively.
“AR882 has the potential to transform gout treatment. The data collected in our Phase 2a study has shown that AR882 is well-tolerated, with robust serum urate lowering effect in patients with gout,” said Arthrosi‘s Chief Medical Officer Robert T. Keenan, MD, MPH, MBA. “We are confident the data will show similar efficacy, safety, and tolerability in this study, which is even larger and longer than the 2a study. The current standard of care has been ineffective in controlling rising rates of the disease and associated patient morbidity. AR882 was designed to treat patients with chronic gout to achieve serum urate levels below 6 mg/dL needed to control disease, and to achieve a target below 5 mg/dL or 4 mg/dL for more aggressive treatment.”