Arthrosi Therapeutics, Inc., a clinical-stage biotechnology company, has announced they have received written response from the U.S. Food and Drug Administration (FDA) related to their End-of-Phase 2 briefing package for AR882, its lead drug candidate for gout treatment. AR882 is a highly potent, selective, and once daily dosing next-gen URAT1 inhibitor. The feedback from the FDA supports Arthrosi progressing with its planned Phase 3 clinical program.
“We were pleased with the response from the FDA on the end-of-phase 2 strategy for nonclinical and clinical development of AR882,” noted Litain Yeh, PhD, CEO of Arthrosi. “We look forward to our upcoming Phase 3 clinical trial, with the intent of accumulating robust data that could pave the way to enriching the treatment landscape for gout patients. There is a clear and pressing need for innovative therapies, like AR882, for patients struggling with gout.”
The company remains committed to progressing its research, with the overarching goal of improving gout treatment options and patient outcomes.
In the U.S., an estimated 9 million individuals are diagnosed with gout. 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, 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. Elevated serum uric acid (sUA) levels often signify an imbalance in production or excretion of uric acid, and they act as an early indicator of potential gout development. Consistent, elevated sUA levels have been identified as a precursor to gout attacks and related complications. It’s essential to monitor and manage these levels as part of comprehensive gout treatment and prevention strategies.
Arthrosi Therapeutics, Inc., headquartered in San Diego, CA, was established in 2018. The company’s goal is to develop potential treatments aimed at uric acid levels and minimizing joint damage for gout patients. Arthrosi’s research and development have produced end of phase 2b data.
Shunqi Yan, PhD
Founder & Chief Operating Officer
SOURCE Arthrosi Therapeutics