— REDUCE 2 is a global study that will
evaluate reduction of sUA in gout patients and support a New Drug
Application (NDA) submission package —
— REDUCE 2 will be conducted in
parallel with a replicate study REDUCE 1, expected to initiate in
the second half of 2024 —
SAN
DIEGO, June 27, 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 reduce serum urate levels, flares and
Tophi in patients with gout, today announced that it has dosed the
first patient in REDUCE 2, a pivotal Phase 3 clinical trial to
evaluate reduction of sUA in gout patients.
"We are pleased to announce the dosing of the first patient in
our pivotal Phase 3 trial evaluating AR882. Uncontrolled gout
represents a significant unmet medical need with approximately two
million patients in the U.S. alone who could benefit from a safer
and more efficacious treatment option," commented Litain Yeh,
Founder and CEO of Arthrosi Therapeutics. "We look forward to
building upon our comprehensive data package of AR882 including the
positive results from our Phase 2 AR882-202 and AR882-203 studies,
which collectively demonstrated significant reduction in serum
urate (sUA) levels as well as a significant decrease of tophi,
crystal burden and flare rates compared to standard of care. This
continued progress underscores our commitment to developing a
safer, more efficacious and convenient therapy to reduce sUA levels
in patients living with gout. We look forward to rapidly enrolling
patients in the study and expect to initiate the second pivotal
REDUCE 1 study in the second half of 2024."
REDUCE 2 is a pivotal twelve-month, randomized, double-blind,
placebo-controlled study. The study is expected to enroll up to 750
patients globally with gout who are inadequate responders to urate
lowering therapies (ULTs) and ULT naïve. Patients will be
randomized into one of three groups either receiving AR882 50 mg,
AR882 75mg or placebo. All patients will receive Prophylaxis at
least 10 days prior to dosing and continue for 3 months. The
primary endpoint is reduction of sUA by month six. Secondary
endpoints include a reduction in flare and tophi over time. The
trial is expected to be completed in late 2026.
About Gout:
In the U.S., an estimated 13 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 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. Gout
remains a large and growing market with ~ 13M patients in the U.S. alone, ~2M of which have
tophaceous gout. AR882 has demonstrated encouraging efficacy and
safety compared to SOC in Phase 2 studies as well as impressive
results in achieving complete resolution of tophi in a Phase
2b study. Arthrosi is currently
advancing AR882 in a pivotal phase 3 program.
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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/arthrosi-announces-first-patient-dosed-in-pivotal-phase-3-reduce-2-trial-of-lead-compound-ar882-302183434.html
SOURCE Arthrosi Therapeutics