Key Points
- Recaticimab effectiveness demonstrated dosage-dependent response indicating versatility in treatment options.
- Sustained reduction in LDL-C levels throughout the 48-week study period as well as favorable outcomes observed in additional lipid variables.
Recaticimab represents an innovative and novel approach in cardiovascular therapeutics as a long-acting monoclonal antibody (mAb) targeting proprotein convertase subtilisin/kexin type 9 (PCSK9). Specifically, it belongs to the immunoglobulin G1 (IgG1) class, showing its distinctiveness in modulating PCSK9 activity and contributing to the expanding landscape of therapeutic interventions for hyperlipidemia and cardiovascular health.
The REMAIN-2 trial, a phase 3, multicenter, randomized, double-blind, placebo-controlled study conducted in China, aimed to evaluate the long-term efficacy and safety of recaticimab (SHR-1209), as an add-on therapy for patients with non-familial hypercholesterolemia (non-FH) and mixed hyperlipidemia. Patients were assigned to three different dosage regimens of recaticimab(150 mg Q4W, 300 mg Q8W, and 450 mg Q12W) or placebo injections for 48 weeks. The primary efficacy endpoint was the percentage change from baseline to week 24 in calculated LDL-C levels.
A total of 692 patients were included. Results indicated a significant and dose-dependent reduction in LDL-C levels with recaticimab compared to placebo, demonstrating treatment differences of -62.2%, -59.7%, and -53.4% for the respective dosage regimens. LDL-C goal (defined as <1.8 mmol/L for patients with ASCVD and <2.6 mmol/L for those without) was achieved by 85.8-94.5% of recaticimab-treated patients at week 24. Importantly, these reductions were sustained throughout the 48-week duration of the trial. Favorable outcomes were also observed in other lipid variables.
The safety profile of recaticimab was comparable to the placebo group, with similar rates of adverse events over 48 weeks. Common adverse events in recaticimab recipients included upper respiratory tract infection, hyperuricaemia, urinary tract infection, increased blood CPK, COVID-19 infection, increased ALT, and increased AST.
Principal investigator Xin Du highlighted that The REMAIN-2 trial provides encouraging evidence for the effectiveness and safety of recaticimab as an add-on therapy for non-familial hypercholesterolaemia and mixed hyperlipidemia. Recaticimab achieved a comparable reduction in essential lipid parameters as other PCSK9 inhibitors, offering additional confirmation of significant benefits with the treatment, even with a less frequent dosing schedule.
