NewAmsterdam Pharma Company (NAMS) 2024 Cantor Fitzgerald Global Healthcare Conference summary

Company overview and drug profile

• Obicetrapib is a potent CETP inhibitor with strong LDL-lowering effects and excellent tolerability, showing additional benefits such as Lp(a) and small particle reduction, and potential diabetes prevention.

• The drug is being developed both as monotherapy and in a fixed-dose combination with ezetimibe, aiming for greater efficacy.

• Phase 2 and 3 trials have demonstrated consistent LDL reductions of 36%-40%, with up to 58% when combined with ezetimibe.

• Obicetrapib addresses unmet needs in lipid management, offering an oral alternative to injectables and overcoming statin limitations.

Clinical development and trial updates

• BROADWAY, a 2,500-patient phase 3 monotherapy trial, is set to read out in Q4, focusing on high-risk patients on various background therapies.

• TANDEM, a fixed-dose combination trial, will report in Q1 next year, aiming to show additive efficacy of obicetrapib and ezetimibe.

• BROOKLYN phase 3 trial showed 36% LDL reduction at 12 weeks and 41% at one year, with strong safety and consistent efficacy across patient subgroups.

• No significant blood pressure effects have been observed, addressing concerns from earlier CETP inhibitors.

Mechanistic insights and competitive positioning

• Obicetrapib lowers LDL by upregulating LDL receptors, shifting LDL particles to larger, more easily cleared forms, and enhancing cholesterol efflux via the intestines.

• The drug robustly lowers Lp(a) and small LDL particles, addressing residual cardiovascular risk not managed by statins.

• Ongoing studies are evaluating additive effects with PCSK9 inhibitors and the commercial opportunity in broader Lp(a) patient populations.

• The company sees oral PCSK9s as expanding the market and believes obicetrapib's broader benefits and tolerability offer a superior profile.