On September 1, at the European Society of Cardiology Congress 2025 (ESC Congress 2025) held in Madrid, Spain, the Phase Ib/IIa clinical trial data for YN001, the first innovative drug from Innova Pharma designed to reverse atherosclerotic plaques, was released globally for the first time. A clinical expert representative delivered an oral presentation titled "Active Targeted Liposomal Drug Significantly Reverses Atherosclerotic Plaques: A Proof-of-Concept Phase Ib/IIa Clinical Trial," reporting for the first time the remarkable efficacy and safety results from the YN001 Phase Ib/IIa study.
A review published in the authoritative international medical journal The Lancet in 2025 pointed out that the current model for diagnosing and managing coronary artery disease, centered on ischemia and cardiovascular events, has limitations. Symptoms do not address the root cause of the disease, and current clinical treatment overly focuses on symptom recognition and acute event management, missing opportunities for early detection and prevention. Insufficient attention is paid to atherosclerotic plaque rupture or erosion, the primary cause of myocardial infarction. The article proposes that clinical practice must shift from primarily focusing on "ischemia" intervention to earlier, proactive intervention targeting "the atherosclerotic plaque itself," suggesting this represents a crucial future path for atherosclerosis prevention and treatment.
YN001 is precisely such an innovative drug that actively targets and reverses atherosclerotic plaques. Its core value lies in the targeted delivery of the active drug, concentrating it at the site of atherosclerotic plaques to act directly on the plaques themselves, achieving plaque volume reduction and stabilization, thereby potentially significantly reducing major adverse cardiovascular events (MACE). YN001 received IND approvals from the US FDA and China's NMPA in 2022 and 2023, respectively.
Results from the Phase Ib/IIa clinical trial showed that compared to the control group, patients receiving YN001 treatment had a significant reduction in total atheroma volume (TAV) and percent atheroma volume (PAV) in coronary arteries from baseline levels, as assessed by imaging modalities such as intravascular ultrasound (IVUS) and coronary computed tomography angiography (CCTA). TAV reduction ranged from 10% to 50%, and PAV reduction ranged from 10% to 30%. Additionally, carotid artery plaque and peripheral vascular plaque areas were markedly reduced in these patients.
Authoritative studies have confirmed a significant correlation between plaque volume, characteristics, carotid intima-media thickness (IMT), and the risk of MACE: For every 1% absolute reduction in PAV, the risk of MACE decreases by 25%; for every 0.01 mm reduction in carotid IMT, the risk of MACE decreases by 9%.
By significantly reducing key indicators like PAV and IMT, YN001 demonstrates a highly significant "plaque reversal" effect, suggesting the potential to substantially lower the risk of MACE in patients with cardiovascular disease. These positive results provide a solid scientific basis for shifting the goal of atherosclerosis treatment from "slowing progression" to "achieving regression." As the first drug preliminarily validated in clinical trials to achieve significant plaque regression, YN001 has the potential to become a major breakthrough new drug for the prevention and treatment of atherosclerosis.