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Associated Press
2 days ago
- Health
- Associated Press
Arthrosi Presents Positive Long-Term Safety and Efficacy Data for Pozdeutinurad (AR882) at the European Alliance of Associations for Rheumatology (EULAR) Congress 2025
Data demonstrates that pozdeutinurad alone or in combination achieves significant reduction in sUA levels in patients with tophaceous gout up to 18 months of treatment Pozdeutinurad's long-term use was well tolerated and comparable to standard of care, with no incidences of elevated serum creatine or clinically significant liver function abnormalities SAN DIEGO, June 12, 2025 /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 (sUA) levels, flares, and dissolve tophi in gout and tophaceous gout patients, today announced long term treatment data from the Phase 2 trial extension period evaluating patient outcomes up to 18 months of treatment with pozdeutinurad (formerly known as AR882). Detailed results will be presented at the European Alliance of Associations for Rheumatology (EULAR) Congress 2025 meeting, being held June 11-14, 2025, in Barcelona, Spain. 'The long-term data from our Phase 2 trial evaluating pozdeutinurad continues to build on the body of evidence differentiating it as a potentially transformative, best-in-class treatment option for patients with gout and tophaceous gout,' said Arthrosi's Chief Medical Officer Robert T. Keenan, MD, MPH, MBA. 'The significant and sustained reduction in sUA over 18 months observed in both the monotherapy and combination groups demonstrates better efficacy to standard of care alone. In addition, the high response rates of complete tophi resolution as well as rapid resolution of total urate crystal volume represent unprecedented quality of life improvements for patients living with gout. We have already fully enrolled the Phase 3 REDUCE 2 global trial and are rapidly enrolling patients in the ongoing Phase 3 REDUCE 1 trial.' The long term safety and efficacy data will be presented in both oral and poster presentations at EULAR. New Clinical Data for Pozdeutinurad Show: Presentation Details: Title: Sustained Efficacy of Pozdeutinurad (AR882): Long-Term Effect of a Novel and Selective URAT1 Inhibitor in Patients with Chronic Gouty Arthritis. Presenting Author: Robert Keenan, M.D., Chief Medical Officer of Arthrosi Therapeutics Format: Poster presentation Abstract Number: POS1307 Date and Time: Saturday, June 14, 2025, 10:00am-3:00pm CEST Title: Safety and Tolerability of Pozdeutinurad (AR882) Treatment following Long-term Dosing in Patients with Chronic Gouty Arthritis and Subcutaneous Tophi. Presenting Author: Robert Keenan, M.D., Chief Medical Officer of Arthrosi Therapeutics Format: Oral presentation Abstract Number: OP0300 Date and Time: Friday, June 13, 2025, 10:30am CEST About the AR882-203 Phase 2 Study: The Phase 2 study of pozdeutinurad (AR882) in patients with tophaceous gout was a six-month 1:1:1 randomized, global, placebo-controlled study of 42 patients with subcutaneous tophi. The mean baseline sUA among the participants ranged between 9.1-9.6 mg/dL. In the main treatment period, patients received a once daily dose of either 75 mg AR882, 50mg AR882 + allopurinol, or allopurinol up to 300mg. Serum uric acid levels (< 6, <5, <4, or <3 mg/dL) were evaluated monthly through month 6 and continued evaluated up to Month 18, and safety and tolerability were assessed throughout the study. Tophi measurements with calipers were completed every 4 weeks for 6 months and throughout the study. Patients were also imaged using Dual-Energy Computed Tomography (DECT), DECT a specialized imaging technique that is able to differentiate and identify uric acid crystals in the joints and soft tissue, allowing for quantifying uric acid crystal deposition and tophi at baseline, 6, 12, and 18 months. About Gout: In the U.S., an estimated 13 million individuals are diagnosed with gout, ~2 million of which have tophaceous gout. Gout is a form of inflammatory arthritis that can significantly diminish mobility, functionality, and overall quality of life. Gout emerges from the crystallization of uric acid within the joints and soft tissue, instigating painful flare-ups and chronic symptoms. The kidneys play a pivotal role in the process, as they are responsible for filtering out and excreting uric acid from the body. In over 90% of gout patients, underexcretion of uric acid results in the imbalanced and elevated sUA levels that can lead to the deposition of uric acid crystals. It's essential to monitor and manage sUA levels as part of comprehensive gout treatment and prevention strategies. About Arthrosi: Arthrosi Therapeutics, Inc., headquartered in San Diego, CA, is focused on developing pozdeutinurad (AR882), 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. Pozdeutinurad has demonstrated encouraging efficacy and safety compared to SOC in Phase 2 studies as well as impressive results in achieving complete resolution of tophi in a Phase 2b study. Arthrosi is currently advancing pozdeutinurad in a pivotal Phase 3 program. Media Contact: Shunqi Yan, PhD Founder & Chief Operating Officer [email protected] Investor Contact: Precision AQ Alex Lobo 212-698-8802 [email protected] View original content to download multimedia: SOURCE Arthrosi Therapeutics
Associated Press
05-03-2025
- Health
- Associated Press
Arthrosi Therapeutics Completes Enrollment in Pivotal Phase 3 REDUCE 2 Trial of AR882 for the Treatment of Gout and Tophaceous Gout
— REDUCE 2 enrollment completed well ahead of schedule— — Plan to initiate replicate Phase 3 trial, REDUCE 1, in 1Q25 — SAN DIEGO, March 5, 2025 /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 (sUA) levels, flares, and dissolve tophi in gout and tophaceous gout patients, today announced the completion of enrollment for its pivotal global Phase 3 REDUCE 2 trial. 'We would like to thank the gout community for its support, trust and participation as we complete this important step in the advancement of the AR882 program,' said Dr. Robert T. Keenan, MD, MPH, Chief Medical Officer of Arthrosi Therapeutics. 'Previous Phase 2 studies have shown a rapid and clinically meaningful decrease in sUA and tophi size, giving us confidence in our ability to bring this potentially transformative, novel treatment to patients living with gout and significantly improve their quality of life.' REDUCE 2 is a pivotal twelve-month, randomized, double-blind, placebo-controlled study. The study has reached its target enrollment of 750 patients globally with a majority being inadequate responders to urate lowering therapies (ULTs). Patients are randomized into one of three groups either receiving AR882 50 mg, AR882 75mg or placebo. The primary endpoint is reduction of sUA by month six. Secondary endpoints include a reduction in flares and tophi over time. The trial is expected to be completed in the first half of 2026. For more information about REDUCE 2, please visit (identifier NCT06439602). About Arthrosi: Arthrosi Therapeutics, Inc., headquartered in San Diego, CA, is focused on developing AR882, 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. AR882 has demonstrated encouraging efficacy and safety compared to SOC in Phase 2 studies as well as impressive results in achieving complete resolution of tophi in a Phase 2b study. Arthrosi is currently advancing AR882 in a pivotal Phase 3 program. About Gout: In the U.S., an estimated 13 million individuals are diagnosed with gout, ~2 million of which have tophaceous gout. Gout is a form of inflammatory arthritis that can significantly diminish mobility, functionality, and overall quality of life. Gout emerges from the crystallization of uric acid within the joints and soft tissue, instigating painful flare-ups and chronic symptoms. The kidneys play a pivotal role in the process, as they are responsible for filtering out and excreting uric acid from the body. In over 90% of gout patients, underexcretion of uric acid results in the imbalanced and elevated sUA levels that can lead to the deposition of uric acid crystals. It's essential to monitor and manage sUA levels as part of comprehensive gout treatment and prevention strategies. Media Contact: Shunqi Yan, PhD Investor Contact: Precision AQ Alex Lobo 212-698-8802
