Nanjing, China, May 31, 2026 — Frontier Biotech announced today the presentation of preclinical data for its first-in-class dual-target small interfering RNA (siRNA) drug candidate FB7033 at the EASL Congress 2026, in both poster and poster tour formats. EASL Congress is one of the most influential global scientific meetings in the field of hepatology.
Metabolic dysfunction–associated steatohepatitis (MASH) is a complex disease driven by multiple pathological mechanisms. Single-target intervention could be limited by broad patient coverage and efficacy, making a multi-target intervention strategy an important approach in new drug development. FB7033 is designed to simultaneously silence two targets—HSD17β13 and CIDEB—with the aim of reducing lipid synthesis, enhancing lipid oxidation, and alleviating lipotoxicity, inflammation, and fibrosis, thereby potentially slowing disease progression and promoting MASH remission.
Data reported at the meeting showed a single subcutaneous dose of FB7033 in cynomolgus monkeys achieved strong and durable knockdown of both targets, with maximal inhibition exceeding 95% for each. The pharmacodynamic effect lasted for at least four months, suggesting a potential dosing interval of six months in humans.
In a validated cynomolgus monkey MASH NHP model, FB7033 significantly improved key disease-related parameters, including MRI-proton density fat fraction (MRI-PDFF) and NAFLD activity score (NAS). Its efficacy data were superior to that of the marketed drug resmetirom and the single-target siRNA ARO-HSD (GSK4532990). Notably, at week 16 after the first dose, liver cell ballooning was completely resolved (score reduced to 0) in the mid-dose group, indicating potential reversal of hepatocellular injury. In addition, 100% of treated animals achieved a NAS reduction of ≥2 points, suggesting broad improvement across MASH pathology.
Safety assessments, including off-target evaluation, immunotoxicity studies, and preliminary toxicology in rats, showed a favorable safety profile. Frontier is currently advancing its development in IND-enabling studies.
Expert commentary
Professor Wei Lai, a leading hepatology expert in China and Executive Director of the Department of Hepatobiliary Medicine at Beijing Tsinghua Changgung Hospital, stated that the preclinical data of FB7033 are remarkable in the context of MASH drug development. MASH is a highly prevalent chronic liver disease globally, driven by multiple interconnected pathological processes including metabolic dysfunction, inflammation, and fibrosis. As a result, multi-target or combination strategies may offer improved outcomes through synergistic effects.
Currently, only two drugs have been approved for MASH, and there remains a significant unmet clinical need. Emerging research suggests that HSD17β13 and CIDEB are involved in different pathological stages of the disease and represent promising therapeutic targets. Early studies of single-target approaches have already shown potential benefits in MASH models.
He further commented that FB7033, a bispecific siRNA designed to silence both HSD17β13 and CIDEB within the same hepatocyte, represents a significant and differentiated innovation in the field. The preclinical results presented at the meeting demonstrated sustained and potent target knockdown, along with improvements in hepatic steatosis, NAS score, and ballooning in the MASH NHP model, with potential synergistic effects compared with single-target approaches. This dual-target strategy may allow coordinated modulation of lipotoxicity, inflammation, and fibrosis pathways, offering a promising candidate for further development. Naturally, the transition from preclinical findings to clinical efficacy requires confirmation through systematic clinical trials.
It is estimated that the number of MASH patients worldwide may reach hundreds of millions in the future, while China alone has tens of millions of adult cases, with incidence continuing to rise annually. A substantial proportion of patients with fibrotic MASH may eventually progress to end-stage liver disease, requiring liver transplantation as the only life-sustaining option, placing a heavy burden on patients, families, and healthcare systems.