AR882 / Arthrosi - LARVOL DELTA

Sustained Efficacy of Pozdeutinurad (AR882): Long-Term Treatment Effect of a Novel and Selective URAT1 Inhibitor in Patients with Chronic Gouty Arthritis (EULAR 2025) - No abstract available

Clinical • Immunology • Inflammatory Arthritis • Rheumatology

Safety and Tolerability of Pozdeutinurad (AR882) Treatment following Long-term Dosing in Patients with Chronic Gouty Arthritis and Subcutaneous Tophi (EULAR 2025) - No abstract available

Clinical • Immunology • Inflammatory Arthritis • Rheumatology

Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-302) (clinicaltrials.gov) - P3 | N=750 | Active, not recruiting | Sponsor: Arthrosi Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Gout • Immunology • Inflammatory Arthritis • Rheumatology

Arthrosi Announces First Patient Dosed in Replicate Pivotal Phase 3 REDUCE 1 Trial of Lead Compound AR882 (PRNewswire) - "Arthrosi Therapeutics, Inc...today announced that it has dosed the first patient in REDUCE 1, the Company's second pivotal Phase 3 clinical trial evaluating AR882....The trial is expected to be fully enrolled in 2025 and completed by the end of 2026."

Trial status • Gout

Arthrosi Therapeutics Completes Enrollment in Pivotal Phase 3 REDUCE 2 Trial of AR882 for the Treatment of Gout and Tophaceous Gout (PRNewswire) - "Arthrosi Therapeutics, Inc...today announced the completion of enrollment for its pivotal global Phase 3 REDUCE 2 trial...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."

Enrollment closed • Trial completion date • Gout

Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-301) (clinicaltrials.gov) - P3 | N=750 | Recruiting | Sponsor: Arthrosi Therapeutics

New P3 trial • Gout • Immunology • Inflammatory Arthritis • Rheumatology

Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination with Allopurinol in Patients with Tophaceous Gout (clinicaltrials.gov) - P2 | N=42 | Completed | Sponsor: Arthrosi Therapeutics | Active, not recruiting ➔ Completed

Trial completion • Gout • Immunology • Inflammatory Arthritis • Rheumatology

Phase II/III Study of AR882 Capsules Compared to Febuxostat Tablets in Patients with Primary Gout and Hyperuricemia (clinicaltrials.gov) - P2/3 | N=636 | Active, not recruiting | Sponsor: Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd

New P2/3 trial • Gout • Inflammatory Arthritis • Rheumatology

A drug-drug interaction trial between AR882, fluconazole, carbamazepine, celecoxib, and sulfasalazine in healthy particpants (ANZCTR) - P1 | N=54 | Completed | Sponsor: Arthrosi Therapeutics Australia Pty, Ltd a subsidiary of Arthrosi Therapeutics, Inc | Recruiting ➔ Completed

Trial completion • Gout • Inflammatory Arthritis • Rheumatology • CYP2C9

Arthrosi Therapeutics Receives FDA Fast Track Designation for AR882 in Tophaceous Gout (PRNewswire) - "Arthrosi Therapeutics, Inc...announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to AR882 for the potential treatment of clinically visible tophi in patients with gout."

Fast track • Gout • Immunology

A drug-drug interaction trial between AR882, fluconazole, carbamazepine, celecoxib, and sulfasalazine in healthy particpants (ANZCTR) - P1 | N=54 | Recruiting | Sponsor: Arthrosi Therapeutics Australia Pty, Ltd a subsidiary of Arthrosi Therapeutics, Inc | Active, not recruiting ➔ Recruiting | N=40 ➔ 54

Enrollment change • Enrollment open • Gout • Inflammatory Arthritis • Rheumatology • CYP2C9

AR882, A SELECTIVE URAT1 INHIBITOR, EXHIBITS NO DRUG-DRUG INTERACTIONS WITH KEY RENAL, HEPATIC, AND GI TRANSPORTERS (EULAR 2024) - "In order to determine the clinical significance of AR882's DDI potential with BCRP, a phase 1 clinical study dosed in 10 male healthy participants with sulfasalazine 500 mg on Day 1, followed by a second single dose of sulfasalazine 500 mg on Day 4 with multiple-dose of AR882 75 mg administered once daily from Days 4 to 6. AR882 has been comprehensively evaluated for transporter-mediated DDI potential in vitro and in clinical studies, and exhibited no DDI concerns. These findings demonstrated that AR882 can be safely given in gout patients with various comorbid conditions including diabetes, hypertension and hyperlipidemia and the concomitant medications that are primarily cleared via transporters."

Cardiovascular • Diabetes • Dyslipidemia • Gout • Hypertension • Immunology • Inflammatory Arthritis • Metabolic Disorders • Rheumatology • SLC22A1

AR882, A NOVEL AND SELECTIVE URAT1 INHIBITOR, SIGNIFICANTLY REDUCED TOPHI IN PATIENTS WITH CHRONIC GOUTY ARTHRITIS: RESULTS OF 12-MONTH OUTCOME FROM A GLOBAL TRIAL USING DIGITAL CALIPER MEASUREMENTS AND DUAL ENERGY COMPUTED TOMOGRAPHY (EULAR 2024) - "The patients were randomized equally into three treatment groups to receive AR882 75 mg once daily (QD), AR882 50 mg + allopurinol QD, or allopurinol up to 300 mg QD. The 12-month treatment of AR882 in patients with tophaceous gout demonstrated safe and efficacious sUA lowering, continued tophus resolution and total crystal volume dissolution from initial 6-month treatment. AR882 may offer improved efficacy and better safety compared to existing therapies in the treatment of patients with gout, including those with both clinically visible and subclinical crystal deposition."

Clinical • Gout • Immunology • Infectious Disease • Inflammatory Arthritis • Pain • Respiratory Diseases • Rheumatology

Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (clinicaltrials.gov) - P3 | N=750 | Recruiting | Sponsor: Arthrosi Therapeutics

New P3 trial • Gout • Immunology • Inflammatory Arthritis • Rheumatology

Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout (clinicaltrials.gov) - P2 | N=42 | Active, not recruiting | Sponsor: Arthrosi Therapeutics | Trial completion date: Feb 2024 ➔ Aug 2024 | Trial primary completion date: Feb 2024 ➔ Aug 2024

Combination therapy • Trial completion date • Trial primary completion date • Gout • Immunology • Inflammatory Arthritis • Rheumatology

A drug-drug interaction trial between AR882, fluconazole, carbamazepine, celecoxib, and sulfasalazine in healthy particpants (ANZCTR) - P1 | N=40 | Active, not recruiting | Sponsor: Arthrosi Therapeutics Australia Pty, Ltd a subsidiary of Arthrosi Therapeutics, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Gout • Inflammatory Arthritis • Rheumatology • CYP2C9

AR882, an Efficacious and Selective URAT1 Inhibitor for Patients with Chronic Gouty Arthritis and Subcutaneous Tophi: Results from a Global, Prospective, Proof-of-Concept Trial Using Dual Energy Computed Tomography (ACR Convergence 2023) - "This proof-of-concept trial evaluates the effect of AR882 versus allopurinol on the reduction of clinically visible tophi in patients with gout using caliper measurements and Dual Energy Computer Tomography (DECT). In this global study, six-month treatment of AR882 demonstrated safe and efficacious sUA lowering, tophus resolution and total crystal volume dissolution in gout patients with various demographics and baseline characteristics. AR882 may offer improved efficacy and better safety compared to existing therapies in the treatment of patients with gout, including those with both clinically visible and subclinical crystal deposition."

Clinical • Late-breaking abstract • Gout • Immunology • Infectious Disease • Inflammatory Arthritis • Pain • Respiratory Diseases • Rheumatology

AR882, a Potent Uricosuric Agent, Shows Favorable Uric Acid Excretion Profile Following Multiple Doses (ACR Convergence 2023) - "With its unique, slower elimination in PK, AR882 maintains a smooth intra-day uric acid excretion profile that was similar to baseline or to that in placebo patients, resulting in a lasting inhibitory effect without any high concentration of uric acid influx in the kidney tubules. The lack of daily transient increase in uric acid excretion confirms AR882, as a new uricosuric agent, possessing a favorable and safe renal profile over existing and other approved uricosuric agents."

Gout • Inflammatory Arthritis • Renal Disease • Rheumatology

Pharmacokinetics and Pharmacodynamics of AR882 Following 12-Week Treatment in Patients with Gout (ACR Convergence 2023) - "In a subset of patients with full PK/PD collection, AR882 showed potent sUA lowering effect with similar exposures to those observed in closely monitored early-phase studies. AR882 50 mg and 75 mg doses were well tolerated during the entire study with an unremarkable safety profile."

Clinical • PK/PD data • Gout • Infectious Disease • Inflammatory Arthritis • Pain • Respiratory Diseases • Rheumatology

Efficacy and Safety of AR882, a Selective Uric Acid Transporter 1 (URAT1) Inhibitor, in Gout Patients with Various Baseline Characteristics Following 12-Week Treatment in Patients (ACR Convergence 2023) - "12-week treatment of AR882 demonstrated safe and efficacious profiles in gout patients with various demographics and baseline characteristics. AR882 may offer improved efficacy and better safety compared to existing therapies in the treatment of patients with gout including those with severe or refractory disease across various demographics and comorbidities."

Clinical • Cardiovascular • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Dyslipidemia • Gout • Hypertension • Immunology • Infectious Disease • Inflammatory Arthritis • Metabolic Disorders • Nephrology • Pain • Renal Disease • Respiratory Diseases • Rheumatology

A drug-drug interaction trial between AR882, fluconazole, carbamazepine, celecoxib, and sulfasalazine in healthy particpants (ANZCTR) - P1 | N=40 | Recruiting | Sponsor: Arthrosi Therapeutics Australia Pty, Ltd a subsidiary of Arthrosi Therapeutics, Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Trial initiation date • Gout • Inflammatory Arthritis • Rheumatology • CYP2C9

A drug-drug interaction trial between AR882, fluconazole, carbamazepine, celecoxib, and sulfasalazine in healthy particpants (ANZCTR) - P1 | N=40 | Not yet recruiting | Sponsor: Arthrosi Therapeutics Australia Pty, Ltd a subsidiary of Arthrosi Therapeutics, Inc

New P1 trial • Gout • Inflammatory Arthritis • Rheumatology • CYP2C9

A 12-Week, Randomized, Double-Blinded, Placebo-Controlled, Phase 2b Study of Safety, Tolerability and Efficacy of AR882 in Gout Patients (EULAR 2023) - "Figure 1. Percent of Patients with sUA at Targets following 12-week Treatment of AR882 or Placebo."

Clinical • P2b data • Cardiovascular • Diabetes • Dyslipidemia • Gout • Hepatology • Hypertension • Infectious Disease • Inflammatory Arthritis • Nephrology • Pain • Pulmonary Disease • Renal Disease • Respiratory Diseases • Rheumatology

Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout (clinicaltrials.gov) - P2 | N=42 | Active, not recruiting | Sponsor: Arthrosi Therapeutics | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2023 ➔ Feb 2024 | Trial primary completion date: Jan 2023 ➔ Feb 2024

Combination therapy • Enrollment closed • Trial completion date • Trial primary completion date • Gout • Immunology • Inflammatory Arthritis • Rheumatology

Phase 2b Evaluation of Efficacy and Safety of AR882 in Gout Patients (clinicaltrials.gov) - P2b | N=140 | Completed | Sponsor: Arthrosi Therapeutics | Active, not recruiting ➔ Completed

Trial completion • Gout • Immunology • Inflammatory Arthritis • Rheumatology