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.
Shunqi Yan, PhD
Founder & Chief Operating Officer
SOURCE Arthrosi Therapeutics