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ARTHROSI TO PRESENT POSITIVE PHASE 2 DATA FOR ITS NOVEL SELECTIVE URAT1 INHIBITOR AR882 IN PATIENTS WITH TOPHACEOUS GOUT AT ACR CONVERGENCE 2023
Arthrosi Therapeutics, Inc., a clinical-stage biotechnology company developing treatments for gout that dissolve uric acid crystals and prevent joint damage, today announced new clinical data from its phase 2 AR882-203 study in patients with tophaceous gout. The late-breaking data will be presented as an oral presentation at the American College of Rheumatology (ACR) Convergence 2023 meeting, being held in San Diego, CA on November 10-15, 2023.
In the forthcoming late-breaking oral presentation, Dr. Robert Keenan MD, MPH, MBA, Chief Medical Officer of Arthrosi, will unveil compelling new clinical findings from the phase 2 trial. The data showcases the strong efficacy of AR882, demonstrating significant reduction of tophi, crystal burden, flare rates, in addition to lowering sUA among patients suffering from tophaceous gout.
In the intent-to-treat population, AR882 demonstrated a significant decrease in sUA at 3 months. Notably, in the 75 mg AR882 group, 86% and 64% of patients achieved sUA levels below 6 and 5 mg/dL, respectively, compared to 77% and 69% in the 50 mg AR882 + allopurinol group and 46% and 23% in the allopurinol group.
Significantly higher response rates in total crystal volume reduction were observed by Dual Energy Computed Tomography (DECT) imaging. Specifically, the AR882 75 mg group showed a notable reduction in total urate crystal volume (-8.3 cm3, baseline 15.6 cm3) compared to allopurinol (-1.2 cm3, baseline 11.5 cm3) or combination (-0.9 cm3, baseline 4.7 cm3) on DECT at Month 6. (Figure 1 illustrates DECT images of one severe gout patient’s crystal burden at baseline (left) and at 6 months following QD treatment of 75 mg AR882).
Consistent with DECT imaging, AR882 75 mg demonstrated significantly higher response rate of at least 1 complete target tophi dissolution by caliper measurement than allopurinol 300 mg, or allopurinol 300 mg in combination with AR882 50 mg. These clinical findings, highlighted via both DECT and caliper, underscore the effectiveness of AR882 in reducing urate crystal burden, further substantiating its potential as a groundbreaking therapeutic solution for patients.
“We are excited to share new data from our phase 2 tophaceous gout study at ACR highlighting its potential to significantly improve the standard of care for a broad range of patients living with gout,” said Arthrosi’s Chief Executive Officer Litain Yeh, PhD. “Importantly, in the case of patients with tophaceous gout, there remains a high unmet need for a safe, efficacious and convenient therapy to reduce sUA levels below 5 mg/dL, which has been established in the literature as necessary to quickly resolve and reduce debilitating symptoms associated with tophi and flares.”
Details for the presentations are below:
Title: 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
Session Title: Late-Breaking Abstracts
Abstract Number: #1651889
Date/Time: Wednesday, November 15 / 7:30am – 7:45am PST
Arthrosi will present three additional posters at ACR highlighting results from its previously completed phase 2b AR882-202 study evaluating AR882 in chronic gout patients. The phase 2b study was a global, multicenter, 12-week, randomized, double-blind, placebo-controlled study of 140 gout patients who met the gout classification according to the American College of Rheumatology (ACR) and The European Alliance of Associations for Rheumatology (EULAR).
Title: 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
Session Title: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster I
Abstract Number: #1553555
Date/Time: Sunday, November 12 / 9:00am – 11:00am PST
Title: Pharmacokinetics and Pharmacodynamics of AR882 Following 12-Week Treatment in Patients with Gout
Session Title: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster II
Abstract Number: #1553704
Date/Time: Monday, November 13 / 9:00am – 11:00am PST
Title: AR882, A Potent Uricosuric Agent, Shows Favorable Uric Acid Excretion Profile Following Multiple Doses
Session Title: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster II
Abstract Number: #1552575
Date/Time: Monday, November 13 / 9:00am – 11:00am PST
All four poster presentations will be available in the “Publications” section of Arthrosi’s website: https://arthrosi.com/publications/.