Topline results from NewAmsterdam’s Phase 3 BROADWAY trial provided the strongest evidence yet of obicetrapib’s potential for patients with ASCVD and heterozygous familial hypercholesterolemia (HeFH) who can’t lower their LDL-C with statins.
- HeFH affects 1 in 250 people worldwide and often makes statin-based LDL-C therapies ineffective due to naturally raising patients’ blood lipid levels.
- Obicetrapib is a potent cholesteryl ester transfer protein inhibitor with a much larger effect on atherogenic lipoproteins than earlier CETP drugs.
The BROADWAY trial randomized ~2.5k patients to take obicetrapib or placebo (2:1 ratio) and monitored them over a 52-week follow up period.
BROADWAY nailed its primary endpoint, as the study’s 1.7k obicetrapib-takers achieved a mean LDL-C reduction of 35% after 84 days, compared to only 2% in the placebo group.
- That’s a major decrease, considering that obicetrapib patients started at 100 mg/dL baseline LDL-C, with nearly 70% reporting high intensity statin use during enrollment.
Obicetrapib also excelled at achieving the study’s secondary endpoints across several biomarkers including ApoB, Lp(a), ApoA1, and HDL-C by day 84, while maintaining LDL-C reductions at days 180 and 365 (-34%).
Even more excitingly, obicetrapib proved exceptionally safe, with blood pressure outcomes similar to placebo and a low treatment discontinuation rate (11.1% obicetrapib vs. 12.4% placebo).
While these LDL-C results were expected based on earlier studies like BROOKLYN and TANDEM, BROADWAY amazingly showed that obicetrapib also slashed MACE, all-cause mortality, and coronary heart death risks over one year (-21%, -17%, -20%).
- Shares of NewAmsterdam soared 41% on the surprise news of MACE reduction, showing just how excited investors are about obicetrapib’s newly expanded potential.
The Takeaway
While BROADWAY confirmed obicetrapib’s previously expected LDL-C effectiveness, the unexpected discovery of its MACE and mortality reductions could propel the drug into the spotlight as NewAmsterdam aims to establish it as a statin-rivaling therapy.
