– Expands Sobi’s pipeline with a highly differentiated new Phase 3 asset in Gout
– Acquisition expected to be highly accretive to Sobi’s mid- to long-term growth and margin trajectory

SAN DIEGO, Dec. 15, 2025 /PRNewswire/ — Arthrosi Therapeutics, Inc., (Arthrosi) has entered into a definitive agreement to be acquired by Sobi^® (STO:SOBI). The acquisition strengthens Sobi’s gout franchise by adding pozdeutinurad (AR882), an investigational next-generation, once-daily oral URAT1 inhibitor currently being evaluated in two fully recruited global Phase 3 clinical studies for the potential management of progressive and tophaceous gout and expected to read out in 2026. Pozdeutinurad complements Sobi’s pipeline by adding a potentially best-in-class URAT1 inhibitor for patients sub-optimally treated with first-line therapies. Today’s announcement reflects Sobi’s commitment to advancing treatment options for people living with gout.

“The acquisition of Arthrosi allows us to expand our gout pipeline with a highly differentiated new asset”, said Guido Oelkers, President and CEO of Sobi. “Pozdeutinurad has the potential to become the therapy of choice for patients who have progressive gout with persistent and unresolved symptoms despite first-line therapy. The product has the potential to materially accelerate our growth until the mid 2030s, and beyond. We welcome all members of the talented Arthrosi team and are looking forward to working closely together to be able to offer this therapy to patients as soon as possible.”

“We are thrilled to join forces with Sobi and look forward to working together to ensure a seamless transition as they advance pozdeutinurad towards pivotal data and potential regulatory filings. We believe that Sobi’s global expertise in commercialisation will accelerate our shared mission to deliver pozdeutinurad’s potentially transformative benefits for individuals living with gout”, stated Litain Yeh, Ph.D., Founder and CEO of Arthrosi Therapeutics.

Transaction details
Under the terms of the agreement, Sobi will pay USD 950 million (approximately SEK 9.1 billion) upfront in cash to acquire Arthrosi, together with up to USD 550 m (approximately SEK 5.3 billion) in cash in clinical, regulatory and sales milestones.

The transaction is subject to the satisfaction of customary closing conditions and is expected to close in H1 2026.

Sobi plans to fund the upfront payment mainly through debt in the form of existing credit facilities and a new credit facility provided by Handelsbanken and Danske Bank.

The acquisition is expected to be highly accretive to Sobi’s mid- to long-term growth and margin trajectory.

Barclays Bank PLC is acting as Sobi’s financial advisor and McDermott, Will & Schulte is acting as legal advisor to Sobi on this transaction. Centerview Partners LLC is serving as exclusive financial advisor to Arthrosi Therapeutics, and Goodwin Procter LLP is serving as legal counsel to Arthrosi Therapeutics.

About Pozdeutinurad
Pozdeutinurad (AR882) is an investigational URAT1 inhibitor being developed for the treatment of progressive and tophaceous gout and has completed Phase 2 studies that demonstrated compelling efficacy with a sustained reduction of serum uric acid, dissolution of tophi and a well-tolerated safety profile. It is currently being evaluated in two Phase 3 studies, REDUCE 1 and REDUCE 2, two twelve-month, randomized, double-blind, placebo-controlled studies to assess pozdeutinurad’s ability to reduce sUA in patients with progressive and tophaceous gout. Both Phase 3 studies are now fully enrolled, and the pivotal data is expected in 2026.

About Arthrosi
Arthrosi Therapeutics, Inc., headquartered in San Diego, CA, is focused on developing pozdeutinurad, a potentially best-in-class, highly potent and selective next generation URAT1 inhibitor to reduce serum urate levels, flares and tophi in patients with progressive gout. The rights to pozdeutinurad in Greater China are held by ApicHope.

About Gout
Gout is the most common form of inflammatory arthritis. Gout is caused by high levels of uric acid in the body that accumulate around the joints and other tissues and can result in flares that cause intense pain. When gout is left untreated, it can become a progressive disease with serious consequences. Over time, frequent flares and persistent uric acid buildup can lead to chronic joint damage, reduced mobility, and the formation of tophi (hard deposits under the skin). While many patients with chronic gout are treated in first line with urate lowering therapy some are sub-optimally treated or do not respond to first line therapies and the disease progresses. In later lines, uncontrolled gout is associated with a higher risk of comorbidities such as kidney disease and cardiovascular complications, making early diagnosis and effective management critical. Despite available treatments, many patients struggle to achieve target uric acid levels, underscoring the need for innovative therapies to prevent long-term disability and improve quality of life.

Sobi^®
Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 1,900 employees across Europe, North America, the Middle East, Asia and Australia. In 2024, revenue amounted to SEK 26 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.

Contacts
For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here.

Gerard Tobin
Head of Investor Relations

Arthrosi Contact:
Shunqi Yan, PhD
Founder & Chief Operating Officer
shunqi.yan@arthrosi.com

Precision AQ Contact:
Alex Lobo
212-698-8802
alex.lobo@precisionaq.com

Enrollment complete in the replicate REDUCE 1 and REDUCE 2 Phase 3 studies with pivotal data expected in Q2 2026

SAN DIEGO, Oct. 8, 2025 /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 (sUA) levels, flares, and dissolve tophi in gout and tophaceous gout patients, today announced the closing of its $153 million Series E financing led by Prime Eight Capital Limited and with participation from CR Biotech,HighLight Capital, HM Venture Partners, , ReliantTech Limited and existing shareholders.

Arthrosi plans to use the proceeds from this financing to complete the clinical development of its lead program, pozdeutinurad (AR882), through its replicate Phase 3 REDUCE 1 and REDUCE 2 studies evaluating pozdeutinurad for the treatment of gout and tophaceous gout. These twelve-month, randomized, double-blind, placebo-controlled studies are designed to assess pozdeutinurad’s ability to reduce sUA in patients with gout and tophaceous gout. Secondary endpoints include reduction in flares and tophi over time. Both Phase 3 trials are now fully enrolled, and the Company expects to report pivotal data in Q2 2026.

“We are delighted to have the continued support of an experienced and deeply committed group of investors,” said Litain Yeh, Ph.D., Founder and CEO of Arthrosi Therapeutics. “Arthrosi continues to make rapid progress on our mission to transform the treatment landscape for gout and tophaceous gout, an area with pressing unmet need. The commitment from both new and existing investors provides further validation for pozdeutinurad and the robust clinical data package we have generated to date. With their support, we look forward to advancing our pivotal Phase 3 program as we work to deliver pozdeutinurad’s potentially transformative benefits to patients as soon as possible.”

“We’re excited to partner with Arthrosi as they advance pozdeutinurad through late-stage development,” said Prime Eight Capital. “The company’s strong management team with a focus on execution gives us confidence in Arthrosi’s ability to deliver a potentially best-in-class treatment for gout. We share their vision to make pozdeutinurad accessible to patients globally and are proud to support a team with the expertise, discipline, and urgency to make that vision a reality.”

About Arthrosi:
Arthrosi Therapeutics, Inc., headquartered in San Diego, CA, is focused on developing pozdeutinurad (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. Pozdeutinurad 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 pozdeutinurad in a pivotal Phase 3 program.

About Gout:
In the U.S., an estimated 13 million individuals are diagnosed with gout, ~2 million of which have tophaceous 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.

Arthrosi Contact:
Shunqi Yan, PhD
Founder & Chief Operating Officer
shunqi.yan@arthrosi.com

Precision AQ Contact:
Alex Lobo
212-698-8802
alex.lobo@precisionaq.com

SOURCE Arthrosi Therapeutics

—     Enrollment completed well ahead of schedule; both Phase 3 trials now fully enrolled with data expected in Q2 2026 —

SAN DIEGO, Aug. 20, 2025 /PRNewswire/ — Arthrosi Therapeutics, Inc., a late-stage biotechnology company advancing a potentially best-in-class, highly potent and selective next generation URAT1 inhibitor to reduce serum urate (sUA) levels, flares, and dissolve tophi in gout and tophaceous gout patients, today announced the completion of patient enrollment in its second pivotal global Phase 3 trial, REDUCE 1, evaluating pozdeutinurad (formerly AR882) for the reduction of sUA and tophi in gout and tophaceous gout patients.

“Following the full enrollment of our REDUCE 2 trial in Q1 2025, we are pleased to announce that REDUCE 1 has also reached full enrollment well ahead of schedule. This milestone marks another critical step towards our mission of delivering a much-needed, differentiated treatment option for patients with gout and tophaceous gout. The remarkable pace of enrollment in both our REDUCE 1 and REDUCE 2 studies is a testament to the strong demand among clinicians and patients for safer and more effective treatments for this painful and often debilitating disease,” said Dr. Robert T. Keenan, MD, MPH, Chief Medical Officer at Arthrosi Therapeutics. “With both of our Phase 3 trials now fully enrolled, we remain on track to deliver data in the second and fourth quarter of 2026 for both Phase 3 trials to support a planned NDA submission for pozdeutinurad. We’re grateful to the investigators, caregivers, and patients for their continued enthusiasm and participation in our Phase 3 program.”

REDUCE 1 is a pivotal twelve-month, randomized, double-blind, placebo-controlled study evaluating pozdeutinurad. The study has reached its target enrollment of 750 patients globally with a majority being inadequate responders to urate lowering therapies (ULTs). Patients are randomized into one of three groups either receiving pozdeutinurad 50 mg, pozdeutinurad 75mg or placebo. The primary endpoint is reduction of sUA by month six. Secondary endpoints include tophi and flare reduction. The company expects to share a comprehensive data update in Q4 2026.

About Arthrosi:
Arthrosi Therapeutics, Inc., headquartered in San Diego, CA, is focused on developing pozdeutinurad (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. Pozdeutinurad 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 pozdeutinurad in a pivotal Phase 3 program.

About Gout:
In the U.S., an estimated 13 million individuals are diagnosed with gout, ~2 million of which have tophaceous 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.

Investor Contact:
Shunqi Yan, PhD
Founder & Chief Operating Officer
shunqi.yan@arthrosi.com

Precision AQ Contact:
Alex Lobo
212-698-8802
alex.lobo@precisionaq.com

SAN DIEGO, June 2, 2025 /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 (sUA) levels, flares, and dissolve tophi in gout and tophaceous gout patients, today announced the acceptance of two presentations at the European Alliance of Associations for Rheumatology (EULAR) Congress 2025 meeting, being held June 11-14, 2025, in Barcelona, Spain.

Presentation Details:

Title: Safety and Tolerability of Pozdeutinurad (AR882) Treatment following Long-term Dosing in Patients with Chronic Gouty Arthritis and Subcutaneous Tophi.
Presenting Author: Robert Keenan, M.D., Chief Medical Officer of Arthrosi Therapeutics
Format: Oral presentation
Abstract Number: OP0300
Date and Time: Friday, June 13, 2025, 10:30am CEST

Title: Sustained Efficacy of Pozdeutinurad (AR882): Long-Term Effect of a Novel and Selective URAT1 Inhibitor in Patients with Chronic Gouty Arthritis.
Presenting Author: Robert Keenan, M.D., Chief Medical Officer of Arthrosi Therapeutics
Format: Poster presentation
Abstract Number: POS1307
Date and Time: Saturday, June 14, 2025, 10:00am-3:00pm CEST

About Gout:

In the U.S., an estimated 13 million individuals are diagnosed with gout, ~2 million of which have tophaceous 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 pozdeutinurad (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. Pozdeutinurad 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 pozdeutinurad 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

— REDUCE 1 enrollment is well ahead of schedule; completion of enrollment expected in 2H 2025 —

— REDUCE 1 is a study running in parallel with REDUCE 2 to evaluate pozdeutinurad’s efficacy in lowering serum urate (sUA) levels and resolution of target tophi in gout patients —

SAN DIEGO, July 1, 2025 /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 (sUA) levels, flares, and dissolve tophi in gout and tophaceous gout patients, today announced that it has enrolled more than 50% of patients in the Company’s second pivotal Phase 3 clinical trial (REDUCE 1) evaluating pozdeutinurad (formerly known as AR882) for the reduction of sUA and tophi in gout and tophaceous gout patients.

“We are excited by the rapid enrollment in the REDUCE 1 study since enrolling our first patient in March 2025, reflecting the enthusiasm from investigators and patients for a potentially transformative treatment option for gout and tophaceous gout,” said Dr. Robert T. Keenan, MD, MPH, Chief Medical Officer at Arthrosi Therapeutics. “Similar to the momentum observed in our fully-enrolled REDUCE 2 study, patient enrollment in REDUCE 1 is well ahead of schedule, and we remain on track to complete enrollment in the second half of this year. We are working tirelessly to advance pozdeutinurad for gout patients in need and look forward to sharing a comprehensive data update in Q2 2026.”

REDUCE 1 is the Company’s second pivotal twelve-month, randomized, double-blind, placebo-controlled study evaluating pozdeutinurad. The study is expected to enroll approximately 750 gout patients including patients with tophi. Patients will be randomized into one of three groups either receiving pozdeutinurad 50 mg, pozdeutinurad 75mg or placebo. The primary endpoint is reduction of sUA by month six. Secondary endpoints include tophi and flare reduction. The trial is expected to be completed by the end of 2026.

For more information about REDUCE 1, please visit https://clinicaltrials.gov/ (identifier NCT06846515).

About Arthrosi:
Arthrosi Therapeutics, Inc., headquartered in San Diego, CA, is focused on developing pozdeutinurad (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. Pozdeutinurad 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 pozdeutinurad in a pivotal Phase 3 program.

About Gout:
In the U.S., an estimated 13 million individuals are diagnosed with gout, ~2 million of which have tophaceous 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.

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

— REDUCE 1 is a study running in parallel with REDUCE 2 to evaluate AR882’s efficacy in lowering serum urate (sUA) levels in gout patients —

SAN DIEGO, March 17, 2025 /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 (sUA) levels, flares, and dissolve tophi in gout and tophaceous gout patients, today announced that it has dosed the first patient in REDUCE 1, the Company’s second pivotal Phase 3 clinical trial evaluating AR882.

“We are pleased to have enrolled the first patient in our REDUCE 1 study, our second confirmatory Phase 3 trial evaluating AR882’s potential as a best-in-class treatment,” said Litain Yeh, Ph.D., Founder and CEO of Arthrosi Therapeutics. “This milestone, together with the rapid completion of enrollment in our Phase 3 REDUCE 2 study, continues to build momentum as we progress towards a New Drug Application for AR882 and deliver a much-needed treatment option that could significantly improve patient outcomes.”

REDUCE 1 is the Company’s second pivotal twelve-month, randomized, double-blind, placebo-controlled study evaluating AR882. The study is expected to enroll up to 750 patients 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 fully enrolled in 2025 and completed by the end of 2026.

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 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.

About Gout:
In the U.S., an estimated 13 million individuals are diagnosed with gout, ~2 million of which have tophaceous 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.

Media Contact:
Shunqi Yan, PhD
Founder & Chief Operating Officer
shunqi.yan@arthrosi.com

Investor Contact:
Precision AQ
Alex Lobo

— REDUCE 2 enrollment completed well ahead of schedule—

— Plan to initiate replicate Phase 3 trial, REDUCE 1, in 1Q25 —

SAN DIEGO, March 5, 2025 /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 (sUA) levels, flares, and dissolve tophi in gout and tophaceous gout patients, today announced the completion of enrollment for its pivotal global Phase 3 REDUCE 2 trial.

“We would like to thank the gout community for its support, trust and participation as we complete this important step in the advancement of the AR882 program,” said Dr. Robert T. Keenan, MD, MPH, Chief Medical Officer of Arthrosi Therapeutics. “Previous Phase 2 studies have shown a rapid and clinically meaningful decrease in sUA and tophi size, giving us confidence in our ability to bring this potentially transformative, novel treatment to patients living with gout and significantly improve their quality of life.”

REDUCE 2 is a pivotal twelve-month, randomized, double-blind, placebo-controlled study. The study has reached its target enrollment of 750 patients globally with a majority being inadequate responders to urate lowering therapies (ULTs). Patients are randomized into one of three groups either receiving AR882 50 mg, AR882 75mg or placebo. The primary endpoint is reduction of sUA by month six. Secondary endpoints include a reduction in flares and tophi over time. The trial is expected to be completed in the first half of 2026.

For more information about REDUCE 2, please visit https://clinicaltrials.gov/ (identifier NCT06439602).

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 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.

About Gout:
In the U.S., an estimated 13 million individuals are diagnosed with gout, ~2 million of which have tophaceous 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.

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

SAN DIEGO, Dec. 18, 2024 — 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 enrolled more than 50% of patients in its pivotal Phase 3 REDUCE 2 trial evaluating AR882 for the reduction of sUA in gout patients.

“We are excited by the momentum we have seen in the REDUCE 2 study since enrolling the first patient in July 2024. This is a reflection of the commitment of our team and clinical collaborators as we seek to redefine the standard of care for patients with gout,” said Litain Yeh, Ph.D., Founder and CEO of Arthrosi Therapeutics. “With our REDUCE 2 study well ahead of its projected schedule, we expect to complete enrollment in the first half of 2025, and in parallel, plan to initiate our REDUCE 1 study, a replicate Phase 3 study in the first quarter of 2025.”

Dr. Robert T. Keenan, MD, MPH, Chief Medical Officer at Arthrosi Therapeutics added, “There remains a large unmet need for a safe and convenient gout treatment, which can provide clinical benefit with reduction of tophi and flares. We remain highly encouraged by the potential of AR882 and believe that our pivotal phase 3 program will support a comprehensive New Drug Application to the U.S. Food and Drug Administration as we seek to improve the lives of all gout patients.”

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 are randomized into one of three groups either receiving AR882 50 mg, AR882 75mg or placebo. All patients 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 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.

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.

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

SOURCE Arthrosi Therapeutics

SAN DIEGO, Aug. 19, 2024 — 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

— 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