This designation is a critical step in accelerating the drug’s development and review process, recognising the urgent need for new treatments in this area.
Arthrosi Therapeutics founder and CEO Litain Yeh said: “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.”
Fast Track Designation supports the development and accelerates the review process of drugs aimed at treating serious conditions and addressing an unmet medical need.
In the US, approximately 13 million individuals are diagnosed with gout, with around two million of these patients with visible tophi. Top of Form
Gout is a form of inflammatory arthritis that significantly affects mobility and quality of life. It is caused by the crystallisation of uric acid within the joints and soft tissue, leading to painful flare-ups. The kidneys, which filter out uric acid, often underexcrete it in gout patients, resulting in elevated serum urate (sUA) levels and crystallisation.
Arthrosi Therapeutics, based in San Diego, California, is developing AR882 as a highly potent and selective next-generation URAT1 inhibitor. The drug aims to reduce serum urate levels, flares, and tophi in patients with gout.
“With our pivotal Phase III clinical program underway, we are committed to working closely with the FDA to accelerate the development of AR882,” Yeh added.
The company’s AR882 has shown promising efficacy and tolerability in nine clinical studies, including in patients with renal impairment and tophaceous gout.
Arthrosi Therapeutics is now advancing AR882 in a pivotal Phase III programme.