AR882 Receives Fast Track Designation From the FDA for Treatment of Clinically Visible Tophaceous Gout

The FDA granted AR882 (Arthrosi Therapeutics, Inc) fast track designation for the treatment of patients with clinically visible tophaceous gout. The decision will expedite the review of AR882 to accelerate access of the treatment to patients in need.

The manufacturer is advancing the treatment in a phase 3 program to support a new drug application submission. Image Credit: © toa555 - stock.adobe.com

Gout affects approximately 13 million individuals in the US, of which about 2 million have visible tophi. It is a common, complex form of arthritis characterized by the crystallization of uric acid within the joints and soft tissue, causing sudden, intense attacks of pain, swelling, redness, and tenderness in 1 or more joints, often the big toe. In almost all of patients with gout, reduced production of uric acid disrupts normal serum uric acid levels (sUA), resulting in the buildup of uric acid crystals.¹

AR882 is a novel, highly potent, selective next generation URAT1 inhibitor that has demonstrated clinically meaningful reductions in sUA, visible subcutaneous tophi, and total urate crystal deposition in multiple clinical trials. The fast track designation is based on initial results from the REDUCE 2 global study evaluating the efficacy of AR882. The ongoing trial is expected to finish in late 2026. The study has a primary end point of reduction of sUA by 6 months, with secondary end points including a reduced in flare and tophi over time.^2-4

REDUCE 2 is a 12-month, randomized, double-blind, placebo-controlled study assessing 750 patients globally with gout who do not respond to urate lowering therapies (ULTs) or are ULT naïve. Patients are randomized to receive either AR882 50 mg, AR882 75 mg or placebo. Additionally, all patients will receive prophylaxis 10 days prior to dosing and continuing for 3 months. In June 2024, the first patient began treatment with AR882, and the manufacturer is advancing the treatment in a phase 3 program to support a new drug application submission.^2,3

"Receiving fast track designation for AR882 from the FDA marks a significant milestone for Arthrosi. This highlights the FDA's recognition of the serious and disabling nature of gout in patients with clinically visible tophi and the potential of AR882 to meet this critical medical need," Litain Yeh, PhD, founder and chief executive officer of Arthrosi Therapeutics, said in a news release. "With our pivotal phase 3 clinical program underway, we are committed to working closely with the FDA to accelerate the development of AR882.”²

REFERENCES

1. Gout. Mayo Clinic. November 16, 2022. Accessed August 19, 2024. https://www.mayoclinic.org/diseases-conditions/gout/symptoms-causes/syc-20372897

2. Arthrosi therapeutics receives fda fast track designation for ar882 in tophaceous gout. PR Newswire. August 19, 2024. Accessed August 19, 2024. https://prnmedia.prnewswire.com/news-releases/arthrosi-therapeutics-receives-fda-fast-track-designation-for-ar882-in-tophaceous-gout-302224771.html

3. Arthrosi announces first patient dosed in pivotal phase 3 reduce 2 trial of lead compound ar882. PR Newswire. June 27, 2024. Accessed August 19, 2024. https://prnmedia.prnewswire.com/news-releases/arthrosi-announces-first-patient-dosed-in-pivotal-phase-3-reduce-2-trial-of-lead-compound-ar882-302183434.html

4. Keenan R, Wei JCC, Dalbeth N, et a. POS0268 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. Annals of the Rheumatic Diseases. June 10, 2024. https://ard.bmj.com/content/83/Suppl_1/409.2