Topline results are in from NewAmsterdam Pharma’s BROOKLYN study, showing that obicetrapib safely and effectively reduces LDL cholesterol in patients with heterozygous familial hypercholesterolemia (HeFH) who can’t be effectively treated by current cholesterol drugs.
- Obicetrapib is an once-daily oral medication that inhibits the CETP protein to reduce LDL-C levels and potentially decrease cardiovascular risks.
- The drug achieved solid LDL-C reductions in previous studies, and is now the focus of four pivotal trials, starting with the BROOKLYN study.
The Phase 3 BROOKLYN trial evaluated 10 mg obicetrapib in 354 randomized HeFH patients whose LDL-C wasn’t adequately controlled despite taking maximally tolerated lipid-lowering therapy.
The results appeared quite positive for obicetrapib, which…
- Achieved a 36.3% LDL-C reduction after 84 days (the primary endpoint), and maintained a 41.5% reduction through one year.
- Reduced 51% of patients’ LDL-C levels below 70 mg/dl.
- Drove significant reductions in HDL-C, non-HDL-C, Lp(a), and Apo(B).
- Was well-tolerated, with safety results comparable to placebo, no increases in blood pressure, and lower treatment discontinuation rates (7.6% vs. 14.4%).
Despite these improvements, obicetrapib’s LDL-C reductions in the BROOKLYN study fell short of its previous Phase 2 trial that achieved a 51% average reduction when taken alone, driving NewAmsterdam’s stock price down 28%.
- However, the BROOKLYN patients were already on maximum lipid lowering meds (14% on PCSK9I, 54% on Ezetimibe + HI statin), potentially skewing the trial’s LDL-C reductions.
Either way, these results make obicetrapib’s three other pivotal Phase 3 studies even more high stakes. The BROADWAY, TANDEM, and PREVAIL trials will use obicetrapib alone or with other lipid-lowering drugs across a range of patients, while evaluating cholesterol reduction or cardiovascular outcomes.
The Takeaway
NewAmsterdam still has a long way to go to prove obicetrapib’s value in the crowded lipid-lowering arena, but the BROOKLYN trial is a solid step towards that goal.
It might not have met Wall Street’s LDL-C expectations, but these results seem like good news for the estimated 1.33 million Americans with HeFH, and NewAmsterdam’s wave of forthcoming studies should paint a much clearer picture of how obicetrapib can help an even wider range of patients.
