Arthrosi Therapeutics, Inc., a clinical-stage biotechnology company, today announced positive topline results from its Phase 2b clinical study of AR882 for the treatment of chronic gout, providing a strong foundation to advance into Phase 3 clinical development.

The Phase 2b study was a global, multicenter, 12-week, randomized, double-blind, placebo-controlled study of 140 gout patients who met the gout classification according to the American College of Rheumatology (ACR) and The European Alliance of Associations for Rheumatology (EULAR). The mean baseline serum urate (sUA) among the participants was 8.6 mg/dL. Patients who participated in the study had several major comorbidities, including hypertension (47%), hyperlipidemia (35%), renal insufficiency (34%), arthritis (23%), diabetes (19%), cardiovascular disease (15%), lung disease (11%), and liver disease (5%).

In the study, patients received a daily dose of 50 mg AR882, 75 mg AR882, or matching placebo. The sUA levels (< 6, <5, <4, or <3 mg/dL) were evaluated following 12 weeks of dosing, and safety and tolerability were assessed throughout the study.

Researchers reported significant results following 12 weeks of treatment. Median sUA levels were reduced 59% from baseline 8.6 mg/dL to 3.5 mg/dL with AR882 75 mg dose, and 42% to 5.0 mg/dL with 50 mg dose. No change was observed in the placebo group.

In the 75 mg dose group, 89%, 82%, 63%, and 29% of patients achieved sUA levels of < 6, <5, <4, and <3 mg/dL, respectively. In the 50 mg dose group, 78%, 50%, and 8% of patients achieved sUA levels of < 6, <5, and <4 mg/dL, respectively. The remarkable sUA lowering effect was consistent in the last three visits between weeks 8 and 12 in both 50 mg and 75 mg groups. None of the patients responded in the placebo group.

“Current standards of care have been ineffective in addressing the underlying cause of gout and associated patient morbidity,” said Arthrosi’s Chief Medical Officer Robert T. Keenan, MD, MPH, MBA. “AR882 has not only demonstrated high response rates achieving the minimum sUA target of below 6 mg/dL needed to control the disease, but also demonstrated sufficient potency to achieve targets below 5 mg/dL or 4 mg/dL for faster flare reduction and dissolution of crystal deposition and tophi.”

AR882 was well tolerated. There were no serious adverse events (SAE) in AR882 treated patients. Mild or moderate AEs typically seen in clinical trials such as diarrhea, headache, upper respiratory infection, were observed in this study. Patient comorbidities were stable and did not require any adjustments in management of the diseases while treated with AR882.

“We are delighted to share the positive results from our Phase 2b study and are looking forward to meeting with the regulatory agencies to align on a strategy for the Phase 3 clinical development plans,” said Arthrosi CEO Litain Yeh. “This is a major milestone for the development of AR882 for chronic gout treatment.”

The researchers plan to present the full details of the study at an upcoming scientific conference. The data will also be submitted for publication to a peer-reviewed rheumatology journal.

Arthrosi Therapeutics, Inc. was founded in San Diego, CA, in 2018 with a mission to create a revolutionary treatment option to target uric acid levels and reduce joint damage for people living with gout. With its vast therapeutic and treatment knowledge, Arthrosi has accumulated a comprehensive and robust intellectual property portfolio and impressive Phase 1 and Phase 2 data showing industry leading efficacy rates and superior safety profiles.

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

SOURCE Arthrosi Therapeutics

Arthrosi Therapeutics, Inc., a clinical-stage biotechnology company, today announced the completion of enrollment for its global Phase 2b clinical study of AR882 for the treatment of chronic gout. The study, which exceeded the initial target enrollment of 120 patients, is designed to evaluate the safety and efficacy of AR882, an effective and selective uricosuric agent, in chronic gout patients who meet ACR/EULAR gout classification.

“We are pleased to see the completion of enrollment in our global Phase 2b clinical study of our leading compound, AR882. The study has exceeded our initial enrollment target despite the COVID-19 pandemic. This is a major milestone for the development of AR882 for chronic gout treatment,” said Arthrosi CEO Litain Yeh.  “I thank the patients who enrolled in this study, the efforts of clinical investigators from the U.S., Australia, and Taiwan, and our clinical operations team who worked diligently to advance the study to this point. We look forward to providing a clinical update later this year.”

About the Study

The Phase 2b randomized, double-blind, placebo-controlled, multicenter clinical study is designed to enroll approximately 120 gout patients to assess safety and efficacy of AR882 in three cohorts: 50 mg, 75 mg, or placebo. Study participants will receive treatment for up to three months to evaluate serum urate (sUA) reduction and safety. A total of 24 clinical sites have participated. As of August 15, 2022, 92 patients and 75 patients have passed the six-week and three-month dosing milestones respectively.

“AR882 has the potential to transform gout treatment. The data collected in our Phase 2a study has shown that AR882 is well-tolerated, with robust serum urate lowering effect in patients with gout,” said Arthrosi’s Chief Medical Officer Robert T. Keenan, MD, MPH, MBA. “We are confident the data will show similar efficacy, safety, and tolerability in this study, which is even larger and longer than the 2a study. The current standard of care has been ineffective in controlling rising rates of the disease and associated patient morbidity. AR882 was designed to treat patients with chronic gout to achieve serum urate levels below 6 mg/dL needed to control disease, and to achieve a target below 5 mg/dL or 4 mg/dL for more aggressive treatment.”

About Arthrosi

Arthrosi Therapeutics, Inc. was founded in San Diego, CA, in 2018 with a mission to create a revolutionary treatment option to target uric acid levels and reduce joint damage for people living with gout. With its vast therapeutic and treatment knowledge, Arthrosi has accumulated a comprehensive and robust intellectual property portfolio and impressive Phase 1 and Phase 2 data showing industry leading efficacy rates and superior safety profiles.

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

SOURCE Arthrosi Therapeutics

Arthrosi Therapeutics, Inc., a clinical-stage biotechnology company focused on treatment for the management of gout, today announced the completion of its renal impairment study utilizing the lead compound, AR882. AR882 is a potent and selective uricosuric agent, which has shown effectiveness lowering serum urate in patients with normal renal function, and in patients with mild to severe renal impairment.

“We have conducted the renal impairment study to include subjects with normal renal function, mild, moderate, and severe renal impairment and a subset of type 2 diabetes patients with albuminuria, which is a clinical manifestation of chronic kidney disease (CKD). The data demonstrated that AR882 is potent and well-tolerated for patients with various degrees of renal impairment, including patients with type 2 diabetes,” said Arthrosi CEO Litain Yeh.

The Study

AR882 was administered as a 100 mg single oral dose to subjects with normal renal function (n=8), mild renal impairment (n=8), moderate renal impairment (n=8), and severe renal impairment (n=6). In a separate cohort, an additional 16 subjects were enrolled to evaluate multiple once-daily doses of AR882 at 75 mg in subjects with type 2 diabetes and microalbuminuria (urine albumin/creatinine ratio between 30-300 mg/g, n=6) versus normal healthy subjects (n=10).

In subjects with various renal functions, similar exposure (C_max and AUC) was seen compared to patients with normal renal function. Mean serum urate levels (sUA) were reduced between 50 to 60 percent, regardless of mild or moderate impairment, or normal renal function. In subjects with severe renal impairment, as expected, the sUA reduction was seen at lesser degrees, consistent with reduced excretion of drug levels in the urine.

In type 2 diabetes patients with microalbuminuria, an early sign of kidney disease, preliminary data shows reduction in Uric Acid-to-Creatinine Ratio (UACR) from screening or baseline following dosing. AR882 was well-tolerated in renally impaired subjects, showing a similar safety profile to that observed in healthy volunteer studies.

“We are pleased to see similar efficacy and levels of AR882 in patients with chronic kidney disease. The results suggest that no dose adjustment will likely be needed in patients with various degrees of renal function. The UACR lowering effect of AR882 in type 2 diabetes patients with impaired kidney function, though in small sample size, suggests AR882 could be a promising new option for treatment of CKD patients with hyperuricemia but will need further validation,” said Arthrosi’s Chief Medical Officer Dr. Robert T. Keenan.

About Arthrosi

Arthrosi Therapeutics, Inc. was founded in San Diego, CA, in 2018 with a mission to create a revolutionary treatment option to target uric acid levels and reduce joint damage for people living with gout. With its vast therapeutic and treatment knowledge, Arthrosi has accumulated a comprehensive and robust intellectual property portfolio and impressive Phase 1 and Phase 2 data showing industry leading efficacy rates and superior safety profiles.

Media Contact:

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

SOURCE Arthrosi Therapeutics

Arthrosi Therapeutics, Inc., a clinical-stage biotech company developing a new uricosuric agent for the management of hyperuricemia in patients with gout, announced today the appointment of Philip Moody as its Chief Financial Officer (CFO). Mr. Moody is a highly accomplished CFO who brings more than 25 years of experience and a track record of success working in private and public biotech companies.

“I am pleased to welcome Philip Moody to the Arthrosi team,” said Co-Founder and CEO Litain Yeh. “I’m confident that his deep and extensive experience in leading the financial operations of life science and technology companies – as well as driving improved financial results – will make an immediate impact as we continue to position Arthrosi for the future.”

Mr. Moody joins Arthrosi from PaxVax, a private equity-backed specialty company where he served as CFO and Executive Vice President. Prior to PaxVax, Mr. Moody was CFO, North America, for BTG PLC, a publicly traded medical device and specialty pharmaceutical company that was acquired by Boston Scientific. Additionally, he served as CFO and Vice President of Finance and Operations for publicly traded Peplin, Inc., an oncology therapeutics company. Mr. Moody began his biotech career at Chiron Corporation, where he progressed to the role of CFO and Senior Vice President of Finance and Operations, Biopharmaceuticals.

“I am thrilled to join Arthrosi as CFO,” said Moody. “I’m excited to be part of a company responsible for a revolutionary gout treatment — and look forward to helping to lead the team in many areas of finance and operations.”

As CFO, Moody will be responsible for accounting, treasury, financial planning and analysis, tax, and investor relations.

Mr. Moody completed a BS in Mechanical Engineering from the University of California, Berkeley, and studied finance at its Haas Graduate School of Business.

About Arthrosi

Arthrosi Therapeutics, Inc. was founded in San Diego, CA, in 2018 with a mission to create a revolutionary treatment option to target uric acid levels and reduce joint damage for people living with gout. With its vast therapeutic and treatment knowledge, Arthrosi has accumulated a comprehensive and robust intellectual property portfolio and impressive Phase 1 and Phase 2a data showing industry leading efficacy rates and superior safety profiles.

Media Contact:

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

SOURCE Arthrosi Therapeutics

Arthrosi Therapeutics, Inc., a clinical-stage biotech company announced today patient enrollment in a global phase 2b study of AR882, its novel drug candidate. AR882 is a new uricosuric agent in clinical development for the management of hyperuricemia in patients with gout, including patients with chronic, refractory tophaceous gout.

“AR882 has the potential to be a game-changer in gout treatment,” said Arthrosi CMO Robert T. Keenan, MD. “Gout is a chronic, progressive and debilitating disease. Despite available treatment options, current standards of care have been ineffective in controlling rising rates of the disease and associated patient morbidity. AR882 was designed to treat patients with chronic gout to achieve serum urate (sUA) levels below 6 mg/dL needed to control disease, and specifically to achieve a target below 5 mg/dL or 4 mg/dL to reduce flares and dissolve tophi.”

The Phase 2b, randomized, double-blind, placebo-controlled, multi-center clinical study will enroll approximately 120 gout patients to assess safety and efficacy of AR882 or placebo. Study participants will receive treatment for up to 3 months to evaluate the efficacy of sUA reduction and safety. Approximately 30 clinical sites in the United States, Australia, and Taiwan are expected to participate.

“AR882 has the potential to address an unmet treatment need for patients with chronic gout, and we are excited to begin this Phase 2b clinical study,” said Litain Yeh, PhD, President and CEO of Arthrosi Therapeutics. “With AR882 receiving its first IND clearance in 2020, we have efficiently moved our clinical program into the Phase 2b stage just one year later. I am incredibly proud of our team who initiated this efficacy trial and achieved first patient dosing within 2021.”

About Arthrosi
Arthrosi Therapeutics, Inc. was founded in San Diego, CA, in 2018 with a mission to create a revolutionary treatment option to target uric acid levels and reduce joint damage for people living with gout. With its vast therapeutic and treatment knowledge, Arthrosi has accumulated a comprehensive and robust intellectual property portfolio and impressive Phase 1 and Phase 2a data showing industry leading efficacy rates and superior safety profiles.

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

SOURCE Arthrosi Therapeutics

Arthrosi Therapeutics, Inc., a clinical-stage biotech company announced results from its renal impairment studies and human AME study. The findings will be shared in two posters — “AR882, a Potent and Selective Uricosuric Agent, Showed Effectiveness in Patients with Various Degrees of Renal Impairment” and “AR882, a Novel Uricosuric Agent, Exhibited Favorable Pharmacokinetic Profile and Balanced Excretion and Metabolic Pathways in a Human AME Study” — at the 2021 American College of Rheumatology Convergence. The world’s premier rheumatology experience will be held virtually from November 3-10, with more than 16,500 participants.

“The data is very promising for gout patients with various degrees of renal impairment,” said Arthrosi CEO Litain Yeh. “We’re looking forward to sharing the results of our study at this prestigious event.”

The Study
In subjects with various renal functions, a single dose of AR882 was found to produce mean serum urate levels (sUA) between 50 to 60 percent, regardless of mild, moderate impairment, or normal renal function. These results are consistent to those seen in previous phase 2a study where potent sUA lowering was also seen with gout patients with mild renal impairment in multiple doses. AR882 was well-tolerated in renal impaired subjects following single or multiple doses, showing a similar safety profile to that observed in healthy volunteer studies.

“Phase 2a and earlier studies with AR882 have shown it to be a promising new option for gout patients as a safe and potent urate lowering medication even in those with kidney impairment,” said Arthrosi’s Chief Medical Officer, Dr. Robert T. Keenan.

In addition, a human AME study showed a well-balance metabolic pathway of AR882 following a single oral dosing, with about 34 percent and 55 percent of AR882 excreted in urine and feces, respectively. At least 80 percent of AR882 is absorbed following oral administration. There is no human specific metabolites and AR882 was accounted for greater than 85% of radioactivity in circulation.

About Arthrosi
Arthrosi Therapeutics, Inc. was founded in San Diego, CA, in 2018 with a mission to create a revolutionary treatment option to target uric acid levels and reduce joint damage for people living with gout. With its vast therapeutic and treatment knowledge, Arthrosi has accumulated a comprehensive and robust intellectual property portfolio and impressive Phase 1 and Phase 2a data showing industry leading efficacy rates and superior safety profiles.

To learn more about Arthrosi, visit www.arthrosi.com

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

SOURCE Arthrosi Therapeutics

Arthrosi Therapeutics, Inc. welcomes Robert Thomas Keenan, MD, MPH, MBA, as Chief Medical Officer. Dr. Keenan has spent nearly 20 years in the field of rheumatology, bringing his vast expertise to the team as they reach Phase2b in the clinical development of the next generation molecule for the treatment of gout.

“We are honored to welcome Dr. Robert Keenan to the Arthrosi team,” said Co-Founder and CEO Litain Yeh. “Dr. Keenan brings a significant amount of experience treating refractory gout, and as a key opinion leader in the field of rheumatology, he will help guide our future success.”

Prior to joining Arthrosi, Dr. Keenan spent most of his career at Duke University. Dr. Keenan was the Founding Director of the Gout and Crystal Arthropathy Clinic at Duke University Medical Center. During that time, he also held numerous roles, including Associate Chief Medical officer of the Patient Revenue Management Organization, Vice Chief for Clinical Affairs for the Division of Rheumatology, Medical Director of the Duke Specialty Infusion Center, and Associate Professor of Medicine at Duke University School of Medicine in the Division of Rheumatology and Immunology.

Dr. Keenan has also published several peer-reviewed articles and book chapters on gout. He obtained his undergraduate and Master of Public Health degree from the University of North Carolina at Chapel Hill, his Doctor of Medicine from St. George’s University School of Medicine, Master of Business Administration from the University of Massachusetts-Amherst and completed his Fellowship in Rheumatology at New York University.

“I am thrilled to join Arthrosi as Chief Medical Officer,” said Dr. Keenan. “I look forward to playing a key role in the development and commercialization of this revolutionary gout treatment that has the potential to truly solve the problem of gout by reducing uric acid levels and preventing joint damage.”

About Arthrosi

Arthrosi Therapeutics, Inc. was founded in San Diego, CA, in 2018 with a mission to create a revolutionary treatment option to target uric acid levels and reduce joint damage for people living with gout. With its vast therapeutic and treatment knowledge, Arthrosi has accumulated a comprehensive and robust intellectual property portfolio and impressive Phase 1 and Phase 2a data showing industry leading efficacy rates and superior safety profiles.

To learn more about Arthrosi, visit www.arthrosi.com

Media Contact:

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

SOURCE Arthrosi Therapeutics

Arthrosi Therapeutics, Inc. today announced a joint venture in Guangzhou China with Ruiao Biopharmaceutical Technology Co., Ltd. (“a subsidiary of  ApicHope  Phamaceutical”) to form Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd.

The joint venture will be responsible for the development of AR882 in the greater China area (Mainland China, Hong Kong, Macao, and Taiwan) while Arthrosi Therapeutics, Inc. continues to lead the global development of AR882 in the gout and tophaceous gout population.

In addition, the joint venture will allow Arthrosi to enter the precision medicine oncology therapeutic area by moving AR035, a potent EGFR exon 20 inhibitor targeting non-small cell lung cancer, into IND-enabling stage.

“We are enthusiastic about this opportunity to bring two drug development programs to the China market while collaborating with a leading Chinese pharmaceutical company with strong research, marketing, and sales capabilities. Partnering with ApicHope will accelerate the development of our two groundbreaking drugs in Western countries and in Asia,” said Litain Yeh, PhD, CEO of Arthrosi.

The registered joint venture is anticipated to result in a $34.3 million investment for development in the greater China area, and another $25 million to participate in Arthrosi Therapeutics Series-C equity financing.

“Through this outbound investment and the establishment of a joint venture in China, we will further enrich the company’s product pipeline, provide access to the global market rights of the product, and accelerate the company’s innovative drug portfolio in the field of innovative drugs,” said Hanxiong Li, an  Executive from ApicHope.

About Arthrosi

Arthrosi Therapeutics, Inc. was founded in San Diego, CA, in 2018 with a mission to create a revolutionary treatment option to target uric acid levels and reduce joint damage for people living with gout. With its vast therapeutic and treatment knowledge, Arthrosi has accumulated a comprehensive and robust intellectual property portfolio and impressive Phase 1 and Phase 2a data showing industry leading efficacy rates and superior safety profiles.

About ApicHope

ApicHope Pharmaceutical is an innovative pharmaceutical company with integrated R&D, manufacturing, sales, and distribution capability. It was founded in 2002 and listed on the Shenzhen Stock Exchange in November 2017 (300723.SZ). ApicHope is quality-driven with robust marketing and sales in chronic disease, anti-infectious disease, and pediatrics treatment. ApicHope has been expanding its R&D  into vaccine therapy, precision medicine toward oncology, and ophthalmic drugs.

To learn more about Arthrosi, visit www.arthrosi.com.

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

SOURCE Arthrosi Therapeutics

With AR882 showing strong efficacy and safety profile in Phase 2a study, Arthrosi is accelerating the development and looking to complete the Phase 2 studies by the middle of 2022.

SAN DIEGO, June 1, 2021 – Arthrosi Therapeutics, Inc. announced results from its Phase 2a study investigating the efficacy and safety of its potent urate lowering agent AR882. Arthrosi is transforming the U.S. gout therapeutic market with the first blockbuster-potential molecule to truly solve the problem of gout by reducing uric acid levels and preventing joint damage.

The Phase 2a study, which involved 30 patients with a history of gout with normal renal function or mild renal impairment, found AR882 to be the best-in-class urate lowering agent among in-development and marketed drugs, with the potential to treat all stages of gout.
Key findings included:

• Superiority response rates with 50 mg AR882 compared to other urate lowering agents, including allopurinol and febuxostat

• Stronger serum uric acid (sUA) lowering effects when using AR882 as a mono therapy than any oral agents commercially available

• Same potency among patients with normal renal function and patients with mild renal impairment

• Potential of flare lowering and tophi reduction in longer treatment

• Serum creatinine level was unaffected. There were no SAEs or AEs leading to study drug discontinuation, and no clinically significant trends in any laboratory or ECG parameters were noted. AR882 was well tolerated

“I am delighted with our trial findings that demonstrate AR882’s ability to help people with gout live better lives,” said CEO Litain Yeh. “With over 90% of patients seeing serum urate levels below 5 mg/dL at 50 mg dosing and below 4 mg/dL at 75 mg dosing, the results have exceeded our expectations in terms of safety and efficacy.”

The results will be presented at the upcoming 2021 annual European Congress of Rheumatology (EULAR) on June 2-5, 2021. To further expand the patient population, Arthrosi initiated a study of AR882 in subjects with different degrees of renal impairment and the results are expected to be presented at upcoming scientific meetings.

Given the strong efficacy and safety profile of AR882, Arthrosi is accelerating the development and is looking to complete the phase 2 studies by the middle of 2022. Arthrosi is currently raising Series C funding. Interested investors can reach out to investorrelations@arthrosi.com

About Arthrosi

Arthrosi Therapeutics, Inc. was founded in San Diego, CA, in 2018 with a mission to create a revolutionary treatment option to target uric acid levels and reduce joint damage for people living with gout. With its vast therapeutic and treatment knowledge, Arthrosi has accumulated a comprehensive and robust intellectual property portfolio and impressive Phase 1 and Phase 2a data showing industry leading efficacy rates and superior safety profiles.

To learn more about Arthrosi, visit www.arthrosi.com

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

SOURCE Arthrosi Therapeutics

Our mission is to eliminate the pain of gout with a new era of gout treatment that provides a true solution.

SAN DIEGO, May 10, 2021 – Arthrosi Therapeutics, Inc, a pharmaceutical company founded in 2018 by a team of well-established experts in drug development, announced the first blockbuster-potential molecule, AR882, to treat gout. It will be the first small molecule that exhibits the potential to demonstrate clinical benefits, such as shrinking tophi and reducing flares, through the mechanism of URAT1 inhibition based on its Phase 2a study.

Gout is a debilitating form of inflammatory arthritis affecting roughly 9 million people in the United States. The disease is caused by elevated levels of uric acid crystals in the joints, which can trigger painful and debilitating inflammation. If left untreated, gout can cause tophi, or large, visible bumps made of urate crystals that can cause permanent joint damage.

“A large percentage of the 9 million patients living with gout are undertreated, relying on short-term or sub-optimal treatments that don’t meet their needs,” said Co-Founder and CEO Litain Yeh. “Our mission is to eliminate the pain of gout with a new era of gout treatment that provides a true solution for removing uric acid in the body and preventing the development of tophi.”
After the completion of four clinically robust studies with more than 100 healthy volunteers and gout patients, AR882 has shown unmatched promise, with excellent renal safety profiles and industry-leading efficacy rates.

About Arthrosi
Arthrosi Therapeutics, Inc. was founded in San Diego, CA, in 2018 with a mission to create a revolutionary treatment option to target uric acid levels and reduce joint damage for people living with gout. With its vast therapeutic and treatment knowledge, Arthrosi has accumulated a comprehensive and robust intellectual property portfolio and impressive Phase 1 and Phase 2a data showing industry leading efficacy rates and superior safety profiles.

To learn more about Arthrosi, visit www.arthrosi.com.

Media Contact:
Shunqi Yan, PhD
Founder & Chief Operating Officer

shunqi.yan@arthrosi.com

SOURCE Arthrosi Therapeutics