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FDA Grants Fast Track Designation to Arthrosi's AR882 for Tophaceous Gout

• The FDA has granted Fast Track designation to Arthrosi Therapeutics' AR882 for treating clinically visible tophi in gout patients, expediting its development and review. • AR882, a next-generation URAT1 inhibitor, aims to address the unmet need for effective gout treatments, particularly in patients with visible tophi. • Arthrosi Therapeutics is currently advancing AR882 through a pivotal Phase 3 clinical program, demonstrating its commitment to addressing this critical medical need.

Arthrosi Therapeutics has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for AR882, a highly potent and selective next-generation URAT1 inhibitor, in development for the treatment of clinically visible tophi in patients with gout. This designation is intended to facilitate the development and accelerate the review of drugs that treat serious conditions and fill unmet medical needs.

Significance of Fast Track Designation

The FDA's decision underscores the urgent need for more effective treatments for tophaceous gout, a severe and debilitating form of inflammatory arthritis. Litain Yeh, Ph.D., Founder and CEO of Arthrosi Therapeutics, noted that the designation highlights the FDA's recognition of the serious nature of gout with visible tophi and AR882's potential to address this critical medical need. The company is committed to working closely with the FDA to expedite AR882's development, with a pivotal Phase 3 clinical program currently underway.

Gout and the Need for New Therapies

Gout affects an estimated 13 million individuals in the U.S., with approximately 2 million experiencing visible tophi. This form of inflammatory arthritis results from the crystallization of uric acid within the joints and soft tissues, leading to painful flare-ups and chronic symptoms that significantly impair mobility, functionality, and overall quality of life. In over 90% of gout patients, the underexcretion of uric acid by the kidneys leads to imbalanced and elevated serum urate (sUA) levels, causing uric acid crystal deposition. Current treatment strategies emphasize monitoring and managing sUA levels to prevent flares and tophi formation.

AR882: A Potential Best-in-Class URAT1 Inhibitor

AR882 is being developed as a potentially best-in-class URAT1 inhibitor to reduce serum urate levels, flares, and tophi in gout patients. The drug has demonstrated encouraging efficacy and tolerability across nine clinical studies, including in patients with renal impairment and tophaceous gout. Arthrosi Therapeutics is headquartered in San Diego, CA, and is dedicated to addressing the unmet needs of gout patients through the development of innovative therapies.
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Reference News

[1]
Arthrosi Therapeutics Receives FDA Fast Track Designation for AR882 in Tophaceous Gout
drugs.com · Aug 19, 2024

Arthrosi Therapeutics receives FDA Fast Track Designation for AR882 in treating tophaceous gout, a serious condition aff...

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