On November 8, 2026 (Chicago local time), Frontier Biotech showcased first-in-human (FIH) clinical and preclinical data for its innovative dual-target siRNA candidate FB7023 during a Late Breaking Science oral presentation session at the 2026 American Heart Association (AHA) Scientific Sessions – one of the premier global forums for cardiovascular science and clinical care.
Product Positioning: A Single Molecule Targeting Two Independent ASCVD Risk Factors
Atherosclerotic cardiovascular disease (ASCVD) arises from multiple interacting risk factors. While established interventions exist for low-density lipoprotein cholesterol (LDL-C), lipoprotein(a) (Lp(a)) is largely genetically determined and an independent risk factor for both ASCVD and calcific aortic stenosis. No approved Lp(a)-targeted therapies are currently available. These two pathogenic pathways are relatively independent; lowering one does not necessarily mitigate risk driven by the other.
FB7023 is Frontier Biotech’s proprietary dual-target siRNA candidate designed for ASCVD. It simultaneously silences the PCSK9 and LPA genes with a single molecule to lower both LDL-C and Lp(a). Compared with single-target agents, FB7023 carries mechanistic advantages. As an siRNA therapy, it offers durable efficacy with infrequent dosing, which may improve long-term patient adherence and reduce the chronic disease management burden.
Study Design: Participants with Elevated LDL-C and Lp(a), with Inclisiran as an Active Control
Early clinical data from this first-in-human study offer vital design benchmarks – spanning dose selection, cohort criteria, and active control selection – to guide future FB7023’s clinical development. Mean baseline LDL-C and Lp(a) levels exceeded 3.3 mmol/L and 70 mg/dL, respectively, among enrolled participants, reflecting the lipid profile of the intended target population: participants with dual lipid elevation requiring intensive lipid-lowering therapy. The trial used Inclisiran, an approved PCSK9-targeted siRNA drug, as an active control, enabling a robust head-to-head assessment at equimolar doses within the same study of the lipid-lowering effects of dual-target and single-target siRNAs.
Study Results: Good Safety and Potent Dual-Target Efficacy
A single subcutaneous dose of FB7023 proved safe and well tolerated through 8 weeks, showing no notable injection-site reactions, while delivering robust, dose-dependent reductions in PCSK9, LDL-C, Lp(a), non-HDL-C and apolipoprotein B (ApoB). FB7023 suppressed Lp(a) by over 95% by Week 4, peaking at up to 99% reduction by Week 8.
In an equimolar head-to-head comparison with Inclisiran at Week 8, FB7023 achieved comparable efficacy in lowering PCSK9 (75% vs. 74%) and LDL-C (43% vs. 42%).
Preclinical Findings: Sustained Dual-Target Activity and Potential for Infrequent Dosing
In a spontaneously hyperlipidemic rhesus macaque model with elevated Lp(a), a single subcutaneous FB7023 dose suppressed both PCSK9 and Lp(a) for more than 12 weeks, supporting the potential for six-monthly dosing in humans. Sustained LDL-C lowering was maintained for 12 weeks, with magnitude and duration comparable to Inclisiran, while Lp(a) reduction was similar to Olpasiran.
Summary
Together, the first-in-human and preclinical data provide compelling proof-of-concept for FB7023’s “single molecule, dual benefit” strategy. The biology of Lp(a) is well established. The recently reported Lp(a)HORIZON study results suggest that further exploration of the intensity and timing of intervention in FB7023 development may help determine whether simultaneous inhibition of both targets can translate into clinical benefit.
Expert Commentary
Dr. Huo Yong, Professor and Chief of the Department of Cardiology, Peking University First Hospital, commented:
“FB7023, an siRNA therapy targeting both PCSK9 and LPA, represents an important innovation in the field of cardiovascular lipid metabolism. The FIH data presented at AHA 2026 are highly noteworthy. Preclinical and early clinical findings support its potential to achieve substantial and sustained reductions in both LDL-C and Lp(a), with mechanistic advantages over single-target therapies. The trial enrolled participants with elevated LDL-C and Lp(a), consistent with the intended target population. At equimolar doses, FB7023 matched Inclisiran for PCSK9 knockdown and LDL-C reduction while achieving up to 99% Lp(a) lowering. This FIH study provides preliminary clinical proof-of-concept for the dual-target approach. We look forward to continued clinical advancement of this novel therapy, which may deliver a more comprehensive, convenient lipid-lowering option for high-risk ASCVD participants.”
ASCVD Burden and Market Opportunity
ASCVD remains the leading global cause of death. GBD 2021 data recorded 8.99 million deaths from ischemic heart disease and 3.59 million deaths from ischemic stroke worldwide. Despite available lipid-lowering agents including statins and PCSK9 inhibitors, dyslipidemia treatment and control rates among Chinese adults remain low (10.1% and 4.8%, respectively), and residual cardiovascular risk persists even after LDL-C targets are met.
An estimated 1.4 billion people globally (~20% of the population) have elevated Lp(a), yet only 1–2% are tested, and no Lp(a)-targeted therapies are approved. The unmet clinical need in patients with concurrent LDL-C and Lp(a) elevation underpins FB7023’s design rationale.
The global dyslipidemia drug market is projected to grow from USD 39.8 billion in 2025 to USD 57.4 billion by 2030. The commercial potential of long-acting siRNA lipid-lowering therapy is validated: Inclisiran achieved global sales of USD 1.198 billion in 2025 and was included in China’s NRDL in 2026. Frontier Biotech will accelerate FB7023’s clinical development to deliver an improved therapeutic option for ASCVD.
Source Notes: Global ASCVD mortality and prevalence: GBD 2021; AHA 2025 Heart Disease and Stroke Statistics Update. Chinese dyslipidemia control rates: China Cardiovascular Health and Disease Report 2024. Market forecasts: 2026 public industry analyses. Lp(a) prevalence and testing rates: 2025 European Atherosclerosis Society Global Summit materials. Inclisiran sales: Novartis 2025 annual report.