An experimental drug from NewAmsterdam Pharma has shown it may protect heart health in a Phase 3 study, a finding Wall Street analysts believe boosts the medicine’s chances of improving the outcomes of people with cardiovascular disease in an ongoing, closely watched clinical trial.
NewAmsterdam on Tuesday said the drug, obicetrapib, met its main goal in the third of three late-stage trials. People with either an inherited condition called heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease who received obicetrapib alongside other medicines saw their levels of LDL, or “bad,” cholesterol fall by an average of 33% after 84 days when adjusted for placebo. That result is similar to what was observed in the two previous Phase 3 trials and will form the basis of approval filings NewAmsterdam intends to discuss with U.S. regulators next year, according to the company.
Obicetrapib’s safety profile, including its potential impact on blood pressure — a concern for drugs of its kind, known as CETP inhibitors — were also comparable to a placebo. A higher percentage of patients in the placebo arm dropped out of the trial due to treatment-related side effects, NewAmsterdam said.
Notably, though the study wasn’t set up to definitively prove whether obicetrapib could lower the risk of heart disease-related complications, testing revealed signs of a possible benefit. An exploratory analysis showed treatment was associated with a 21% reduction in cardiovascular events, such as heart attacks or strokes, after a year.
That apparent benefit, which is critical to the uptake of heart drugs, came earlier than management or analysts had anticipated. A detectable difference typically doesn’t occur for at least a year, Jefferies analyst Dennis Ding wrote in a note published in November.
The finding is “strong and unexpected,” Ding wrote on Tuesday. It “meaningfully exceeds our expectations” and “increases our confidence” in the drug succeeding in a cardiovascular outcomes study that’s expected to produce results in 2026, added Matt Phipps, an analyst at William Blair.
NewAmsterdam shares climbed by about 33% in early Tuesday trading.
The result led analysts to ask NewAmsterdam executives on a conference call whether the company might have an early look at data from that study, dubbed Prevail, or report findings more quickly than expected. Michael Davidson, NewAmsterdam’s CEO, said that the company hasn’t decided yet, and added that the Food and Drug Administration has “discouraged” NewAmsterdam from doing so.
According to Davidson, the company also plans to accumulate broader evidence of obicetrapib’s impact on heart disease in that study, “so that may take as long as we have predicted to go forward.” NewAmsterdam intends to have data from Prevail when it launches obicetrapib, he added.
If ultimately approved, obicetrapib would be the first CETP inhibitor to reach market and change the narrative surrounding the drugs, which were largely abandoned by pharmaceutical companies last decade due to poor clinical performance and safety concerns.
Yet, obicetrapib would compete with an array of other therapies, among them generic statins and injectable PCSK9 inhibitors. An oral PCSK9 blocker and drugs that impact another genetic risk factor of heart health, lipoprotein(a), are in advanced testing too, making obicetrapib’s effects on cardiovascular outcomes in the Prevail study — which was designed similarly to the trial that read out on Tuesday — crucial to its prospects.
“This is a mini-outcomes study in some respects,” Davidson told analysts. “We purposely set it up this way to try to further de-risk Prevail going forward.”
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- Source: https://www.biopharmadive.com/news/newamsterdam-obicetrapib-broadway-mace-study-results/735083/