Findings show lingdolinurad, a novel orally administered URAT1 inhibitor, achieved its primary endpoint in lowering uric acid and demonstrated good safety and tolerability
ZHEJIANG, China--(BUSINESS WIRE)--Atom Therapeutics Co., Ltd, a clinical stage biotechnology company developing best-in-class treatments for metabolic and inflammatory diseases, announced today its global Phase 2b/3 clinical trial of lingdolinurad (ABP-671), a novel orally administered URAT1 inhibitor, achieved its primary endpoint with significant efficacy in lowering serum uric acid (sUA) levels and demonstrated good safety and tolerability in treatment of patients with chronic gout.
The multicenter, randomized, double-blind, six month study compared ABP-671 dose groups to allopurinol (Treat-to-Target) and placebo. This study was conducted across four major global regions: United States, Europe, Latin America, and Australia.
Dr. William Dongfang Shi, Atom’s CEO, Chairman and Founder, commented, “Robust clinical data have demonstrated the strong efficacy, safety, and tolerability of ABP-671, positioning it as a leading candidate for best-in-class therapeutic in this area.”
Dr. Shi added, “The six-month global Phase 2b/3 clinical trial provided compelling evidence that ABP-671 is associated with clinically meaningful improvement in reducing the risk of acute gout attacks and promoting tophus dissolution. These findings lay the groundwork for the design and planning of our upcoming pivotal clinical studies.”
The Phase 2b/3 results show the study successfully met all primary and secondary endpoints with significant efficacy. ABP-671 demonstrated outstanding urate lowering effects. Statistical analysis indicated ABP-671 showed a therapeutic advantage over the positive control group receiving up to 800 mg/day of allopurinol under the Treat-to-Target dosing strategy to reach < 6 mg/dL of sUA. Notably, a higher proportion of patients treated with ABP-671 reached more stringent sUA thresholds of < 5 mg/dL and < 4 mg/dL.
Compared to the allopurinol group and placebo group, ABP-671 significantly reduced the relative risk of acute gout attacks with a maximum risk reduction of 42% within the period of 15-28 weeks. During a treatment period of only 6 months, ABP-671 demonstrated good efficacy in dissolving tophi with remarkable reduction in gouty stone compared to baseline levels. The response rate of tophus diameter reduction between baseline and week 28 reached 91%.
ABP-671 also demonstrated good safety and tolerability, and the overall adverse events in the recommended Phase 3 clinical dose group were comparable to those in the placebo group. Compared to other urate lowering drugs such as febuxostat, benzbromarone and some investigational drugs that have shown cardiovascular risks and/or liver toxicity, ABP-671 has not shown any cardiovascular risks or liver toxicity.
The American College of Rheumatology recommends lowering serum uric acid levels in gout patients to < 6 mg/dL to reduce gout flares and long-term joint damage. The British Society for Rheumatology and the European Alliance of Associations for Rheumatology further suggest controlling sUA to < 5 mg/dL to achieve functional remission in some patients.
However, an increasing number of clinical consensus guidelines support maintaining sUA levels at 4 - 5 mg/dL to optimize outcomes in gout management. Sustaining low uric acid levels allows continuous dissolution of tophus in joints and soft tissues, promoting reduction in both the size and number, thereby lowering the frequency of gout flares and ultimately achieving functional remission.
Currently available gout therapies demonstrate insufficient efficacy and are often associated with serious or even life-threatening adverse effects, such as severe hepatotoxicity, nephrotoxicity, higher risk of sudden death, heart disease, or gastrointestinal discomfort, falling far short of the ideal therapeutic needs.
About Atom Therapeutics
Atom Therapeutics 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, lingdolinurad (ABP-671), is currently in late stage clinical trials for chronic gout indication. Another small molecule ABP-745, for anti-inflammatory and autoimmune conditions, has completed Phase 1 clinical trials and demonstrated good pharmacokinetics and safety, and Phase 2 clinical studies are ongoing, with plans to expand Phase 2 trials to multiple indications simultaneously. For more information, please visit: https://www.atomthera.com.
Contacts
Media Contact:
Daniel Eramian
Opus Biotech Communications
http://opusbiotech.com/
425-306-8716
Business Development Contact:
Roy J. Wu, MBA
Sr. Vice President, Business Development
Atom Therapeutics Co., Ltd
Email: roy.wu@atombp.com
