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
shunqi.yan@arthrosi.com
Investor Contact:
Precision AQ
Alex Lobo
212-698-8802
alex.lobo@precisionaq.com
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SOURCE Arthrosi Therapeutics