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Arthrosi Announces Multiple Presentations at the European League Against Rheumatism (EULAR) Congress 2024

 

SAN DIEGOMay 30, 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 the acceptance of two presentations, including one poster tour at the European League Against Rheumatism (EULAR) Congress 2024 meeting, being held in Vienna, Austria on June 12-15.

Details for the poster presentations are as follows:

Title: AR882, a Novel and Selective URAT1 Inhibitor, Significantly Reduced Tophi in Patients with Chronic Gouty Arthritis: Results of 12-month Outcome from a Global Trial using Digital Caliper Measurements and Dual Energy Computed Tomography
Session Title: Clinical Poster Tours: Gout treatment in 2024
Presenting Author: Robert Keenan, M.D., Chief Medical Officer of Arthrosi Therapeutics
Abstract Number: POS0268
Date/Time: Friday, June 14 / 9:30am-10:30am CEST

Title: AR882, a Selective URAT1 Inhibitor, Exhibits No Drug-Drug Interactions with Key Renal, Hepatic, and GI Transporters
Presenting Author: Litain Yeh, Ph.D, Co-Founder and Chief Executive Officer of Arthrosi Therapeutics
Abstract Number: POS0935
Date/Time: Friday, June 14 / 9:30am-10:30am CEST

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 anticipates initiating pivotal phase 3 program in early 2024.

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

Investor Contact:
Stern Investor Relations, Inc.
Alex Lobo
212-698-8802
Alex.lobo@sternir.com

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Arthrosi to Present Positive Phase 2 Data for its Novel Selective URAT1 Inhibitor AR882 in Patients with Tophaceous Gout at ACR Convergence 2023

Arthrosi Therapeutics, Inc., a clinical-stage biotechnology company developing treatments for gout that dissolve uric acid crystals and prevent joint damage, today announced new clinical data from its phase 2 AR882-203 study in patients with tophaceous gout. The late-breaking data will be presented as an oral presentation at the American College of Rheumatology (ACR) Convergence 2023 meeting, being held in San Diego, CA on November 10-15, 2023.

In the forthcoming late-breaking oral presentation, Dr. Robert Keenan MD, MPH, MBA, Chief Medical Officer of Arthrosi, will unveil compelling new clinical findings from the phase 2 trial. The data showcases the strong efficacy of AR882, demonstrating significant reduction of tophi, crystal burden, flare rates, in addition to lowering sUA among patients suffering from tophaceous gout.

In the intent-to-treat population, AR882 demonstrated a significant decrease in sUA at 3 months. Notably, in the 75 mg AR882 group, 86% and 64% of patients achieved sUA levels below 6 and 5 mg/dL, respectively, compared to 77% and 69% in the 50 mg AR882 + allopurinol group and 46% and 23% in the allopurinol group.

Significantly higher response rates in total crystal volume reduction were observed by Dual Energy Computed Tomography (DECT) imaging. Specifically, the AR882 75 mg group showed a notable reduction in total urate crystal volume (-8.3 cm3, baseline 15.6 cm3) compared to allopurinol (-1.2 cm3, baseline 11.5 cm3) or combination (-0.9 cm3, baseline 4.7 cm3) on DECT at Month 6. (Figure 1 illustrates DECT images of one severe gout patient’s crystal burden at baseline (left) and at 6 months following QD treatment of 75 mg AR882).

Consistent with DECT imaging, AR882 75 mg demonstrated significantly higher response rate of at least 1 complete target tophi dissolution by caliper measurement than allopurinol 300 mg, or allopurinol 300 mg in combination with AR882 50 mg. These clinical findings, highlighted via both DECT and caliper, underscore the effectiveness of AR882 in reducing urate crystal burden, further substantiating its potential as a groundbreaking therapeutic solution for patients.

“We are excited to share new data from our phase 2 tophaceous gout study at ACR highlighting its potential to significantly improve the standard of care for a broad range of patients living with gout,” said Arthrosi’s Chief Executive Officer Litain Yeh, PhD. “Importantly, in the case of patients with tophaceous gout, there remains a high unmet need for a safe, efficacious and convenient therapy to reduce sUA levels below 5 mg/dL, which has been established in the literature as necessary to quickly resolve and reduce debilitating symptoms associated with tophi and flares.” 

 

Details for the presentations are below:

Title: AR882, an Efficacious and Selective URAT1 Inhibitor for Patients with Chronic Gouty Arthritis and Subcutaneous Tophi: Results from a Global, Prospective, Proof-of-Concept Trial Using Dual Energy Computed Tomography

Session Title: Late-Breaking Abstracts

Abstract Number: #1651889

Date/Time: Wednesday, November 15 / 7:30am – 7:45am PST

 

Arthrosi will present three additional posters at ACR highlighting results from its previously completed phase 2b AR882-202 study evaluating AR882 in chronic gout patients. 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).

 

Title: Efficacy and Safety of AR882, a Selective Uric Acid Transporter 1 (URAT1) Inhibitor, in Gout Patients with Various Baseline Characteristics Following 12-Week Treatment in Patients

Session Title: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster I

Abstract Number: #1553555

Date/Time: Sunday, November 12 / 9:00am – 11:00am PST

 

Title: Pharmacokinetics and Pharmacodynamics of AR882 Following 12-Week Treatment in Patients with Gout

Session Title: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster II

Abstract Number: #1553704

Date/Time: Monday, November 13 / 9:00am – 11:00am PST

 

Title: AR882, A Potent Uricosuric Agent, Shows Favorable Uric Acid Excretion Profile Following Multiple Doses

Session Title: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster II

Abstract Number: #1552575

Date/Time: Monday, November 13 / 9:00am – 11:00am PST

 

All four poster presentations will be available in the “Publications” section of Arthrosi’s website: https://arthrosi.com/publications/.

 

About the AR882-203 Phase 2 Study

The Phase 2 study of AR882 in patients with tophaceous gout was a six-month, 1:1:1 randomized, global, placebo-controlled study of 42 patients with subcutaneous tophi. The mean baseline sUA among the participants ranged between 9.1-9.6 mg/dL. In the study, patients received a once daily dose of either 75 mg AR882, 50mg AR882 + allopurinol, or allopurinol up to 300mg. Serum uric acid levels (< 6, <5, <4, or <3 mg/dL) were evaluated monthly through month 6, and safety and tolerability were assessed throughout the study. Tophi measurements with calipers were completed every 4 weeks for 6 months. Patients were also imaged using Dual-Energy Computed Tomography (DECT), DECT a specialized imaging technique that is able to differentiate and identify uric acid crystals in the joints and soft tissue, allowing for quantifying uric acid crystals and tophi at baseline and 6 months. The primary efficacy endpoint was sUA change at 3 months. Secondary endpoints included complete resolution of at least one target tophus with no new tophi and no tophus showing progression. Safety assessments, including vital signs and electrocardiograms, were collected throughout the study. 

 

About Gout:

In the U.S., an estimated 10 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. Elevated sUA levels often signify an imbalance in production or excretion of uric acid and acts 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 sUA levels as part of comprehensive gout treatment and prevention strategies.

 

About Arthrosi:

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 anticipates initiating pivotal phase 3 program in early 2024.

 

Media Contact:

Shunqi Yan, PhD

Founder & Chief Operating Officer

shunqi.yan@arthrosi.com

 

Investor Contact:

Stern Investor Relations, Inc.

Alex Lobo

212-698-8802

Alex.lobo@sternir.com

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Arthrosi Announces Multiple Presentations at the American College of Rheumatology (ACR) Convergence 2023

Arthrosi Therapeutics, Inc., a clinical-stage biotechnology company developing treatments to reduce uric acid levels, dissolve uric acid crystals and prevent joint damage in gout patients, today announced the acceptance of three poster presentations and one late breaking oral presentation at the American College of Rheumatology (ACR) Convergence 2023 meeting, being held in San Diego, CA on November 10-15, 2023.

Details for the presentations are as follows:  

Oral Presentation:

Title: AR882, an Efficacious and Selective URAT1 Inhibitor for Patients with Chronic Gouty Arthritis and Subcutaneous Tophi: Results from a Global, Prospective, Proof-of-Concept Trial Using Dual Energy Computed Tomography
Session Title: Late-Breaking Abstracts
Abstract Number: #1651889
Date/Time: Wednesday, November 15 / 7:30 AM – 7:45 AM

Poster Presentations:

Title: Efficacy and Safety of AR882, a Selective Uric Acid Transporter 1 (URAT1) Inhibitor, in Gout Patients with Various Baseline Characteristics Following 12-Week Treatment in Patients
Session Title: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster I
Abstract Number: #1553555
Date/Time: Sunday, November 12 / 9:00am-11:00am PST

Title: Pharmacokinetics and Pharmacodynamics of AR882 Following 12-Week Treatment in Patients with Gout
Session Title: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster II
Abstract Number: #1553704
Date/Time: Monday, November 13 / 9:00am-11:00am PST

Title: AR882, A Potent Uricosuric Agent, Shows Favorable Uric Acid Excretion Profile Following Multiple Doses
Session Title: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster II
Abstract Number: #1552575
Date/Time: Monday, November 13 / 9:00-11:00am PST

About Gout:

In the U.S., an estimated 10 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. Elevated sUA levels often signify an imbalance in production or excretion of uric acid, and acts 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 sUA levels as part of comprehensive gout treatment and prevention strategies.

About Arthrosi:

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 anticipates initiating pivotal phase 3 program in early 2024.

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

Investor Contact:
Stern Investor Relations, Inc.
Alex Lobo
212-698-8802
Alex.lobo@sternir.com

SOURCE Arthrosi Therapeutics

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Arthrosi Therapeutics AR882 Prepares to Enter into Global Phase 3 Study

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.

About Gout:

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.

About Arthrosi:

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.

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

SOURCE Arthrosi Therapeutics

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Arthrosi Secures $75m In Series D Financing

Arthrosi Therapeutics, a clinical-stage biotechnology company, today announced the successful securing of $75 million in Series D financing. This round is led by Guangrun Health Industry (Hong Kong) Co. Limited and backed by a consortium of investors, including Reichstein Biotech (HK) Co. Limited, a subsidiary of ApicHope Pharmaceuticals. The participation of these notable investors underscores their continued confidence and commitment to the development of AR882. This financing represents another milestone in the development of AR882, a highly potent and selective next-gen URAT1 inhibitor delivered in a once daily immediate release oral capsule. AR882 has the potential to change the treatment paradigm for gout, addressing critical aspects such as serum uric acid (sUA) levels, flares, and tophi reduction.

Recent Phase 2b trials have demonstrated remarkable efficacy and safety of AR882, positioning it as a frontrunner in the industry. Notably, 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.

“I am not aware of any other molecule that has shown such promising results,” said Litain Yeh, PhD, and CEO of Arthrosi. “We continue to be extremely positive about how AR882 can address the significant unmet need in the gout space. In the U.S. alone there are 9 million people who suffer with limited treatment options. The Series D financing and continued partnership with ApicHope will accelerate the development of AR882 and other groundbreaking drugs in Western countries and in Asia.”

“We look forward to the continued collaboration with Arthrosi to accelerate the company’s innovative drug portfolio and provide global access to these promising treatments,” said Hanxiong Li, Chairman and CEO of ApicHope. “We have been very impressed with the progress Arthrosi has demonstrated. The results of the Phase 2b trials are exceptional and we expect the ongoing Phase 2 tophi trial to also show improvements in flares, sUA reduction, and tophi.”

With over 9 million gout patients in the U.S. alone and 20 percent of patients with visible tophi, the market potential for AR882 is estimated to be over $1 billion.

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 2b data showing industry leading efficacy rates and superior safety profiles.

About ApicHope

ApicHope Pharmaceutical is an innovative pharmaceutical company with integrated R&D, manufacturing, and sales capabilities. It was founded in 2002 and listed on the Shenzhen Stock Exchange in November 2017 (300723.SZ). ApicHope focuses on the fields of pediatric medicine, chronic disease drugs, and biogenetic vaccines. It is recognized as one of the top 100 comprehensive pharmaceutical research and development companies in China and one of the top 100 pharmaceutical companies in China.

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

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Arthrosi Announces Positive Topline Results For AR882 Phase 2B Study

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.

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

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Arthrosi Completes AR882 Phase 2b Study Enrollment

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

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Arthrosi Completes AR882 Renal Impairment Study

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 (Cmax 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

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Arthrosi Welcomes New Chief Financial Officer

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

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Arthrosi Therapeutics, Inc. Announces Patient Enrollment in Global Phase 2b Study of AR882

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 StatesAustralia, 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