RBD7022 / Suzhou Ribo, Qilu Pharma - LARVOL DELTA

siRNA-mediated inhibition of PCSK9 by RBD7022: a first-in-human trial to evaluate safety, pharmacokinetics (PK) and pharmacodynamic (PD) effects alone and when added to statin treatment. (ESC-WCC 2025) - P1, P2 | "Following SC dosing, RBD7022 was rapidly absorbed with median time to reach maximum plasma concentrations ranging from 1.5-4 hours. Plasma concentrations thereafter declined rapidly with a mean half-life ranging between 3.5- 6.8 hours, consistent with rapid GalNAc-mediated uptake of the siRNA into the liver (Figure 1). There was a dose dependent and sustained (>6 months) suppression of PCSK9 levels (Figure 1) which was saturated at higher multiple doses (mean suppression: -74% at 300 mg, 65% at 500 mg when added to statin treatment), accompanied by robust reductions in LDL-C, ApoB and plasma triglycerides (Figure 2)."

Clinical • P1 data • PK/PD data • Cardiovascular • Dyslipidemia • APOB

Pharmacokinetics and Pharmacodynamics Study (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P1 trial • Dyslipidemia • Metabolic Disorders

A Single and Multiple Ascending Doses Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RBD7022 (clinicaltrials.gov) - P1 | N=80 | Completed | Sponsor: Suzhou Ribo Life Science Co. Ltd. | Active, not recruiting ➔ Completed

Trial completion

Combination therapy with GalNAc-siRNA drugs targeting both PCSK9 and APOC3 resulted in enhanced lipid lowering in mice (ESC 2024) - "Conclusions- The combination of RBD7022 targeting PCSK9 and RBD5044 targeting APOC3 simultaneously reduce LDL-C and TC levels. The combination of RBD7022 and RBD5044 could be a better therapeutic option to further reduce LDL-C, particularly for mixed hyperlipidemia patients and other high-risk individuals with both high LDL-C and high TG levels."

Combination therapy • Preclinical • Atherosclerosis • Cardiovascular • Dyslipidemia

A Single and Multiple Ascending Doses Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RBD7022 (clinicaltrials.gov) - P1 | N=80 | Active, not recruiting | Sponsor: Suzhou Ribo Life Science Co. Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed