On December 16, 2025, Hangzhou Atom Therapeutics Co., Ltd. announced that its Phase II clinical trial application for ABP-745, a small molecule innovative drug in the anti-inflammatory field for the treatment of atherosclerosis, has been approved by the U.S. FDA. The company has initiated a multicenter Phase II clinical trial spanning the United States, China, and Australia, with Academician Ge Junbo, a cardiology expert at Zhongshan Hospital affiliated with Fudan University and an academician of the Chinese Academy of Sciences, serving as the Leading Principal Investigator.
Atherosclerosis is a common cardiovascular disease and a key factor leading to major adverse cardiovascular events (MACE). Cardiovascular diseases caused by atherosclerosis are responsible for an estimated 18 million deaths annually. Factors such as hypertension, hyperlipidemia, hyperglycemia, and inflammation damage the vascular endothelium, promoting the deposition and oxidation of low-density lipoprotein and cholesterol, triggering inflammatory responses, forming foam cells and lipid plaques, and ultimately leading to vascular stenosis, hardening, reduced elasticity, thinning, and even rupture, as well as thrombus formation due to the shedding of unstable plaques, resulting in acute vascular blockage that may trigger myocardial infarction, stroke, and death.
Current treatments for atherosclerosis primarily focus on lipid-lowering therapies, such as statins, ezetimibe, and PCSK9 inhibitors, but precise targeted intervention of inflammatory pathways related to plaque formation has not yet been achieved. Chronic inflammation贯穿 throughout every stage of atherosclerosis development. The release of inflammatory mediators not only further exacerbates endothelial damage, promotes lipid deposition and plaque instability but also increases the risk of plaque rupture, serving as an independent risk factor for cardiovascular events.
Colchicine is the first anti-inflammatory drug approved by the FDA in 2023 for the treatment of cardiovascular disease. On top of standard lipid-lowering therapy, it reduces the risk of major MACE by an additional 31% through the modulation of inflammatory pathways. Recent clinical studies have shown that colchicine can significantly slow the progression of atherosclerotic plaques on top of standard lipid-lowering therapy. Moreover, for every additional 1% reduction in coronary plaque volume, the incidence of MACE decreases by 25%. However, colchicine's narrow safety window limits its dosage, and its drug-drug interactions—such as an increased risk of rhabdomyolysis when used in combination with certain statins—also restrict its clinical application.
ABP-745 is administered orally and has no risk of drug-drug interactions. Studies have shown that its safety window is significantly wider than that of colchicine. ABP-745 inhibits NLRP3 inflammasome activation, suppresses the accumulation of inflammatory cells at plaque sites, and potently inhibits multiple key inflammatory cytokines including IL-1β, IL-6, IL-18, and TNF-α, covering the full-cycle inflammatory pathways of atherosclerosis from endothelial damage to plaque rupture. Additionally, ABP-745's favorable brain penetration suggests it may have a good effect on reducing brain plaques, offering potential for the prevention and treatment of stroke. In mouse studies, compared to model groups, ABP-745 monotherapy reduced aortic plaque area by 56.1%. In another similar study, ABP-745 combined with statins reduced aortic plaque area by over 75%, demonstrating a robust plaque-reducing effect.
ABP-745 has completed Phase I clinical trials in both the United States and China, demonstrating favorable safety, tolerability, and pharmacokinetic profiles. International multicenter Phase II clinical trials for the treatment of "acute gout" are currently underway in the United States, Australia, and China.