The China study confirms a Phase 2a trial in Australia demonstrating ABP-671 significantly reduces serum uric acid levels and is well tolerated
JIANGSU, China--(BUSINESS WIRE)--Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.), a clinical stage biotechnology company developing best in class treatments for inflammatory and metabolic diseases, announced today positive results from its China Phase 2a clinical trial of ABP-671. The randomized, double-blind, placebo-controlled trial enrolled 54 patients with gout or hyperuricemia across six cohorts, with 7 randomized to ABP-671 and 2 to placebo per cohort.
The study successfully reached its main endpoints. At a dose of 1 mg ABP-671 once daily (QD), 86% of patients reached serum uric acid (sUA) levels below 6 mg/dL. Furthermore, 100% of patients achieved sUA levels below 6 mg/dL in multiple higher tested doses. At doses of 6 mg and 12 mg ABP-671 QD, 100% of patients saw their sUA levels drop below 5 mg/dL, and 57% and 100% respectively achieved sUA levels below 4 mg/dL. Importantly, all doses were well tolerated and no significant safety concerns were observed.
"The results from our Phase 2a clinical trial in China are consistent with the findings from our Phase 2a trial in Australia, indicating that ABP-671 can effectively reduce uric acid levels significantly and safely compared to currently marketed gout drugs, which have been associated with serious adverse side effects," said Dr. William Shi, CEO and Chairman of Atom Bioscience. "The consistency of these positive results from our back-to-back clinical trials is encouraging, and we look forward to advancing ABP-671 into pivotal trials in the US and other countries later this year."
The Phase 2a Australian study met its primary objective of lowering sUA levels to below 6 mg/dL and was well tolerated. The study in Australia enrolled 60 gout and hyperuricemia patients randomized to receive daily ABP-671 doses of 2 mg, 4 mg, 8 mg or placebo. Significantly, high proportions of patients who received the treatment experienced a reduction in sUA levels. Nearly 90% of patients receiving 4 mg QD experienced reduction of sUA levels below 6 mg/dL, while 100% and 88% of patients who received 8 mg saw sUA levels drop to < 5 mg/dL and < 4 mg/dL, respectively.
The American College of Rheumatology recommends sUA levels below 6 mg/dL for the prevention of gout flares and long-term joint damage. The British Society of Rheumatology and the European Alliance of Associations for Rheumatology recommend a target sUA level of < 5 mg/dL for tophaceous gout. Current medications in the gout therapeutics market require much higher doses to control chronic gout and are generally accompanied by serious side effects, such as severe hepatotoxicity, nephrotoxicity, higher risk of sudden death, heart disease, or gastrointestinal discomfort.
ABP-671 is a small molecule inhibitor of the urate transporter 1 (URAT1) protein, which is involved in the reabsorption of uric acid by the kidneys. In gout patients, ABP-671 reduces the reabsorption of uric acid, increasing its excretion in urine.
About Atom Bioscience
Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co. Ltd.) is a fast-growing innovative drug company, focused on development of best in class small molecule therapeutics for treatment of inflammatory and metabolic diseases. The company’s lead product, ABP-671, is in late stage clinical development for treatment of chronic gout. For more information please visit: https://atombp.us/
Opus Biotech Communications
Business Development Contact:
Roy J. Wu, MBA
Sr. Vice President, Business Development
Atom Bioscience and Pharmaceutical Co., Ltd
Email: [email protected]