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Obicetrapib’s Unexpected Outcomes | CV Hospital Costs
December 12, 2024
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Together with
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“Obicetrapib is the unsexiest drug doing the sexiest things. Oral, ldl reduction, apoB reduction, LPa reduction, HDL increase, ApoA1 increases, super clean side effect profile, diabetes risk reduction, and possibly more (AD?).”
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Oliver Venture on BROADWAY’s topline results.
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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.
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