Findings from the REMAIN-2 trial presented Nov. 12 at AHA 2023 demonstrated the long-term efficacy and safety of add-on recaticimab as a therapeutic option in patients with non-familial hypercholesterolemia and mixed hyperlipidemia that is inadequately controlled on stable statin therapy. Recaticimab is a new PCSK9 inhibitor that can be injected every one to three months.

The trial, which was based in China, enrolled 689 participants with non-familial hypercholesterolemia and mixed hyperlipidemia that was not controlled by ongoing moderate or high intensity statin therapy. The mean age was 56 years and 64% were men. Participants were divided into three groups, one which received 150 mg of recaticimab or a placebo injection every four weeks, a second receiving 300 mg of recaticimab or placebo injection every eight, and a third receiving 450 mg of recaticimab or placebo injection every 12 weeks.

Overall results showed that participants who received recaticimab, regardless of dosing level, had lower bad cholesterol levels at 24 weeks than those receiving a placebo. These levels were maintained at 48 weeks, researchers said. Specifically, bad cholesterol was reduced 62% among those taking recaticimab in the four-week injection group vs. 0% among those in the placebo group, and reduced by 59% vs. +0.4%, respectively in the 8-week group. In the 12-week injection group, bad cholesterol was reduced 51% vs. +2%, respectively.

In other findings, recaticimab demonstrated a comparable safety profile to placebo, with a similar amount of injection site reactions, including redness and soreness, common across both groups during the 48 weeks. Additionally, other types of lipids like lipoprotein(a) and apolipoprotein B were also reduced significantly in the recaticimab groups compared with the placebo groups.

“Recaticimab reduced these key lipid parameters by a similar magnitude to other PCSK9 inhibitors, providing further evidence of profound benefits with the treatment despite less frequent dosing,” said lead study author Xin Du, PhD, in presenting the findings.