Arthrosi Therapeutics Receives FDA Fast Track Designation for AR882 in Tophaceous Gout

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Aug 19, 2024, 08:00 ET

SAN DIEGO, Aug. 19, 2024 /PRNewswire/ -- Arthrosi Therapeutics, Inc., a late-stage biotechnology company developing a potentially best-in-class, highly potent and selective next generation URAT1 inhibitor to treat gout, today 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.

"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," said Litain Yeh, Ph.D. Founder and CEO of Arthrosi Therapeutics. "With our pivotal Phase 3 clinical program underway, we are committed to working closely with the FDA to accelerate the development of AR882."

Fast Track Designation is a process designed to facilitate development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need.

About Gout:

In the U.S., an estimated 13 million individuals are diagnosed with gout and approximately 2 million of those patients have visible tophi. 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 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 tolerability across a total of nine clinical studies including in patients with renal impairment and tophaceous gout. The Company is currently advancing AR882 in a pivotal Phase 3 program and has been granted Fast Track Designation from the U.S. FDA for patients with clinically visible tophaceous gout.

Media Contact:
Shunqi Yan, PhD
Founder & Chief Operating Officer
[email protected]

Investor Contact:
Precision AQ
Alex Lobo
212-698-8802
[email protected]

SOURCE Arthrosi Therapeutics