REMAIN-2 Trial reveals long-term safety and efficacy of recaticimab in patients with non-FH and mixed hyperlipidemia

Participants were categorized into three groups: one which received 150 mg of recaticimab or a placebo injection every four weeks, the second group received 300 mg of recaticimab or a placebo injection every eight weeks, and the third group received 450 mg of recaticimab or placebo injection every 12 weeks. The primary efficacy endpoint was determined as the percentage change from baseline to week 24 in calculated LDL-C levels.

The researchers reported the following findings:

• 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.
• Bad cholesterol was reduced by 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 by 51% vs. +2%, respectively.
• Recaticimab demonstrated a comparable safety profile to placebo, with a similar amount of injection site reactions, including soreness and redness, common across both groups during the 48 weeks.
• Other types of lipids like lipoprotein(a) and apolipoprotein B were also reduced significantly in the recaticimab groups compared with the placebo groups.

"Our findings provide encouraging evidence for the safety and effectiveness of recaticimab as an add-on therapy for non-familial hypercholesterolaemia and mixed hyperlipidemia," the researchers wrote.

"Recaticimab achieved a comparable reduction in essential lipid parameters as other PCSK9 inhibitors, offering additional confirmation of significant treatment benefits, even with a less frequent dosing schedule," they concluded.