Arthrosi Therapeutics, Inc. today announced that it has dosed the first patient in REDUCE 2, a pivotal Phase 3 clinical trial to evaluate reduction of sUA in gout patients.
| — REDUCE 2 is a global study that will evaluate reduction of sUA in gout patients and support a New Drug Application (NDA) submission package — — REDUCE 2 will be conducted in parallel with a replicate study REDUCE 1, expected to initiate in the second half of 2024 — SAN DIEGO, June 27, 2024 /PRNewswire/ -- Arthrosi Therapeutics, Inc., a late-stage biotechnology company developing a potentially best-in-class, highly potent and selective next generation URAT1 inhibitor to reduce serum urate levels, flares and Tophi in patients with gout, today announced that it has dosed the first patient in REDUCE 2, a pivotal Phase 3 clinical trial to evaluate reduction of sUA in gout patients.
“We are pleased to announce the dosing of the first patient in our pivotal Phase 3 trial evaluating AR882. Uncontrolled gout represents a significant unmet medical need with approximately two million patients in the U.S. alone who could benefit from a safer and more efficacious treatment option,” commented Litain Yeh, Founder and CEO of Arthrosi Therapeutics. “We look forward to building upon our comprehensive data package of AR882 including the positive results from our Phase 2 AR882-202 and AR882-203 studies, which collectively demonstrated significant reduction in serum urate (sUA) levels as well as a significant decrease of tophi, crystal burden and flare rates compared to standard of care. This continued progress underscores our commitment to developing a safer, more efficacious and convenient therapy to reduce sUA levels in patients living with gout. We look forward to rapidly enrolling patients in the study and expect to initiate the second pivotal REDUCE 1 study in the second half of 2024.” REDUCE 2 is a pivotal twelve-month, randomized, double-blind, placebo-controlled study. The study is expected to enroll up to 750 patients globally with gout who are inadequate responders to urate lowering therapies (ULTs) and ULT naïve. Patients will be randomized into one of three groups either receiving AR882 50 mg, AR882 75mg or placebo. All patients will receive Prophylaxis at least 10 days prior to dosing and continue for 3 months. The primary endpoint is reduction of sUA by month six. Secondary endpoints include a reduction in flare and tophi over time. The trial is expected to be completed in late 2026. About Gout: About Arthrosi: Media Contact: Investor Contact:
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