Atom Therapeutics, a clinical stage biotechnology company developing best-in-class treatments for inflammatory and metabolic diseases, today announced FDA approval of a Phase II clinical trial application of ABP-745, a novel anti-inflammatory agent for atherosclerosis. The company has launched a multi-regional Phase II trial globally.

Atherosclerosis is a common cardiovascular disease and a key driver of major adverse cardiovascular events (MACE). Each year, cardiovascular diseases caused by atherosclerosis lead to approximately 18 million deaths worldwide. Risk factors including hypertension, hyperlipidemia, hyperglycemia, and chronic inflammation cause damage to the vascular endothelium, prompting the deposition and oxidation of low-density lipoprotein (LDL) and cholesterol, and eliciting local inflammatory responses. This leads to the formation of foam cells and lipid-rich plaques, ultimately resulting in vascular narrowing, hardening, reduced elasticity, thinning, and even rupture. Rupture of unstable plaques triggers thrombosis, leading to acute vascular stenosis, which may cause severe outcomes including myocardial infarction, stroke, and death.

Current treatments for atherosclerosis primarily rely on lipid-lowering therapies, including statins, ezetimibe, and PCSK9 inhibitors; however, precise targeted intervention against inflammation pathways associated with plaque formation has not yet been achieved. Chronic inflammation is involved in every stage of atherosclerosis. The release of inflammatory mediators not only further aggravates endothelial injury, promotes lipid deposition, and increases plaque instability, but also elevates the risk of plaque rupture, making inflammation an independent risk factor for cardiovascular events.

Colchicine became the first anti-inflammatory drug approved by the FDA in 2023 for the treatment of cardiovascular disease. On top of standard lipid-lowering therapy, colchicine further reduced the risk of MACE by 31% through its anti-inflammatory mechanism. Recent clinical studies have shown that colchicine combining with standard treatment significantly reduces atherosclerotic plaque burden. Notably, 1% regression in plaque volume is associated with a 25% reduction in the odds of MACE. However, the use of colchicine in ASCVD is still limited due to its narrow therapeutic window, which restricts the dosage, and its potential for drug-drug interactions. For example, co-administration with certain statins can further increase the risk of rhabdomyolysis, thereby limiting its broader clinical application.

Dr. William Dongfang Shi, Founder, Chairman and CEO of Atom Therapeutics, commented, “ABP-745’s entry into Phase II clinical trials for atherosclerosis represents a pivotal milestone, marking its expansion into diseases driven by chronic inflammation. This milestone enables Atom Therapeutics to establish a strategic foothold in the dual therapeutic areas of metabolism and cardiovascular diseases, thereby substantially strengthening the company's core competitive edge in inflammatory diseases.”

ABP-745, administered orally, poses no risk of drug-drug interactions. Animal studies have shown that, compared with colchicine, its therapeutic safety window is significantly wider. ABP-745 inhibits activation of the NLRP3 inflammasome, suppresses the recruitment of inflammatory cells to plaque sites, and potently inhibits multiple key inflammatory cytokines, including IL-1β, IL-6, IL-18, TNF-α, and CRP, thereby covering the full inflammatory cascade of atherosclerosis from endothelial injury to plaque rupture. The study in mice showed that the administration of ABP-745 resulted in the reduction of aortic plaque area up to 56.1% compared with the model group. In another similar study, combination therapy of ABP-745 with statins reduced aortic plaque area by more than 75%. ABP-745 has demonstrated robust plaque-lowering effects.

ABP-745 has completed a favorable safety, tolerability and pharmacokinetic profile in its Phase I trial in the U.S. and China. A multi-regional Phase II trial for acute gout flares is currently advancing across the U.S., Australia, and China.

About Atom Therapeutics

Atom Therapeutics Co., Ltd (formerly Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd) is a fast-growing innovative clinical stage biotechnology 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 in late-stage clinical development for treatment of chronic gout. Another small molecule ABP-745, for anti-inflammatory and autoimmune conditions, is in global Phase 2 clinical trials for acute gout. For more information, please visit: https://atomthera.us/

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