SAN DIEGO, 19 August 2024 /PRNewswire/ — Arthrosi Therapeutics, Inc., a late-stage biotechnology company developing a potentially first-in-class, highly potent and selective next-generation URAT1 inhibitor for the treatment of gout, today announced that 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.

“The FDA’s Fast Track approval for AR882 is an important milestone for Arthrosi. It underscores that the FDA recognizes the severity and disabling nature of gout in patients with clinically visible tophi and that AR882 has the potential to address this critical medical need,” said Litain Yeh, Ph.D., founder and CEO of Arthrosi Therapeutics. “With our pivotal Phase 3 clinical program already underway, we are committed to working closely with the FDA to accelerate the development of AR882.”

Fast Track Designation is a procedure designed to facilitate the development and testing of medicines intended to treat serious diseases and to meet unmet medical needs.

About gout:

An estimated 13 million people in the United States are diagnosed with gout, and about 2 million of these patients have visible tophi. Gout is a form of inflammatory arthritis that can significantly affect mobility, functionality, and overall quality of life. Gout results from the crystallization of uric acid in the joints and soft tissues, causing painful flare-ups and chronic symptoms. The kidneys play a critical role in this process, as they are responsible for filtering and excreting uric acid from the body. In over 90% of gout patients, under-excretion of uric acid leads to imbalanced and elevated uric acid levels, which can lead to the deposition of uric acid crystals. It is important to monitor and control uric acid levels as part of comprehensive gout treatment and prevention strategies.

About Arthrosis:

Arthrosi Therapeutics, Inc., based in San Diego, Californiais focused on developing AR882, a potentially best-in-class, highly potent and selective next-generation URAT1 inhibitor for reducing serum uric acid levels, gout flares and tophi in patients with gout. AR882 has demonstrated encouraging efficacy and tolerability in a total of nine clinical trials, including in patients with renal impairment and gouty tophacyanemia. The company is currently advancing AR882 in a pivotal Phase 3 program and has received Fast Track designation from the U.S. FDA for patients with clinically visible gouty tophacyanemia.

Media contact:
Shunqi Yan, PhD
Founder and Chief Operating Officer
(email protected)

Contact for investors:
Precision AQ
Alex Lobo
212-698-8802
(email protected)

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