NewAmsterdam Pharma NASDAQ: NAMS said it plans to conduct an interim analysis of its ongoing PREVAIL cardiovascular outcomes trial (CVOT) for obicetrapib in the fourth quarter of 2026, citing what executives described as encouraging trends in two-year blinded data and a lower-than-anticipated major adverse cardiovascular event (MACE) rate from year one to year two.
Chief Executive Officer Michael Davidson said the interim analysis timing aligns with PREVAIL’s “minimum 2.5-year follow-up,” with results expected in the first quarter of 2027. If the trial does not stop for efficacy at the interim, Davidson said the company “continue[s] to anticipate completion by the end of 2027.”
Interim analysis planned after two-year blinded review
Davidson said the company recently marked the two-year anniversary of the last patient enrolled in PREVAIL and has observed “encouraging trends in the blinded data.” He reiterated prior commentary that the first-year blinded event rate in PREVAIL has been “tracking in line with what we saw in BROADWAY,” the company’s Phase 3 trial that was designed as a “mini PREVAIL,” according to Chief Scientific Officer John Kastelein.
Davidson added that the overall MACE rate from year one to year two has been “lower than anticipated,” which he called encouraging “when viewed against historical LDL-C outcome studies in this population.” That trend contributed to the decision to add an interim look.
PREVAIL’s primary endpoint was also discussed on the call. Davidson said that “with the recent expansion of the primary endpoint of MACE-4 to include total coronary rather than urgent revascularization” and an expected median follow-up of “nearly 3.5 years,” the interim analysis is now expected to occur with “substantially more events” than the roughly 950 events previously projected. He said that increases statistical power for the primary MACE-4 endpoint, while “the statistical power to detect a three-point benefit remains unchanged.”
BROADWAY comparisons and event-rate “slowdown” discussion
Kastelein reviewed outcome signals from BROADWAY, where he said the company saw a “21% reduction” in a predefined exploratory MACE-4 endpoint. He attributed that exploratory signal to multiple possible factors, including changes in LDL particles and lipoprotein(a), and “some room for potentially other factors such as less new-onset type 2 diabetes.”
He described the BROADWAY Kaplan-Meier curves as separating around day 200, with a landmark analysis beginning at six months showing separation in the second half of the first year. Kastelein added that when BROADWAY data are combined with results from BROOKLYN, another Phase 3 pivotal registration trial, the separation “become[s] statistically significant.”
On PREVAIL, Kastelein emphasized similarities with BROADWAY, including baseline LDL around 100 in both studies, and said PREVAIL has “more type 2 diabetics and more post MI patients,” suggesting at least similar or slightly higher ASCVD risk.
Kastelein said PREVAIL’s first-year ASCVD events were trending in line with BROADWAY and described a visualization in which PREVAIL’s Kaplan-Meier curve stays between BROADWAY placebo and active curves after the split, which he called “extremely encouraging.” He added that from year one to year two, the company has seen a “continued trend downward,” and said a slowing of event rates “compares favorably” with other lipid-lowering CVOTs he has worked on, while cautioning that adjudication of year-two events is ongoing.
Questions on power, disclosure, and comparisons to past trials
In response to analyst questions, Davidson said the interim timing reflects the 2.5-year minimum follow-up and that the company expects to have enough events—particularly for 4-point MACE—to support the interim. He said the company believes it would be “powered sufficiently” to detect a benefit if hazard ratios comparable to those seen in BROADWAY’s exploratory endpoint were observed.
Asked what would be disclosed if PREVAIL does not stop for efficacy at the interim, Davidson said investors would learn only that the study continues and was not stopped “for efficacy or futility.” Kastelein added that continuing to the end of the trial would provide more statistical power not only for the primary endpoint but also for secondary endpoints, including “hard MACE endpoints,” which he said have labeling relevance.
Davidson and Kastelein also addressed how they are benchmarking PREVAIL’s event-rate behavior. Davidson said the company has used “AI technology” to model outcomes from other trials, adjusting for baseline characteristics and considering add-on therapies such as GLP-1s, SGLT2s, PCSK9 inhibitors, and others. He cited several recent studies as inputs to their modeling, including FOURIER, CLEAR Outcomes, VESALIUS-CV, SOUL, and SELECT, while noting that VESALIUS-CV differs as a primary prevention trial. Kastelein said the company has assessed “decay rate” in placebo arms across many trials and concluded that what it is seeing in PREVAIL is “beyond decay rates that we’ve witnessed in the last decade.”
Lp(a), CETP history, and additional biological hypotheses
Analysts also asked about potential read-through from Novartis’ pelacarsen HORIZON outcomes trial. Kastelein said NewAmsterdam’s Phase 3 program showed obicetrapib 10 mg once daily lowered lipoprotein(a) by “45%-50%” in a range he described as 50 to 115 nmol/L, adding that those data were accepted for publication in the European Heart Journal that morning. He said if HORIZON is positive, it could help translate the relationship between Lp(a) lowering and ASCVD risk reduction to PREVAIL, but he also said a negative HORIZON readout “doesn’t matter much for us” given BROADWAY’s exploratory MACE reduction.
Davidson added that HORIZON could still be informative even if it shows benefit but does not reach the statistical threshold for approval, and he also noted potential platform-related side effects such as skin reactions.
On CETP inhibitor outcomes history, Kastelein and Davidson referenced the REVEAL trial of anacetrapib. Kastelein said the placebo arm in CETP inhibitor trials has shown decay similar to other placebo arms. Davidson said PREVAIL “pretty much mimics the upper tertile of REVEAL,” and discussed that dataset as one of the comparators the company frequently reviews.
The call also included discussion of small LDL particles as a potential contributor to outcomes beyond LDL-C. Kastelein said small LDL particles are “very atherogenic” and argued CETP activity is important for constructing them, adding that inhibiting CETP activity “by 98%” makes it “very hard to create a small particle.” He said the company has shown in Phase 3 that obicetrapib reduces these particles substantially and called it “reasonable as an hypothesis” that this could contribute to a large effect size.
Regulatory and operational updates; renal signal mentioned
Davidson said the company is “working closely with the FDA” on how the interim analysis may affect filing timelines, describing discussions as ongoing and indicating more details would be provided around the company’s investor day on Aug. 5, 2026. Chief Financial Officer Ian Somaiya added that the company has submitted a trial amendment to institutional review boards and that “several have been cleared and those changes are now in place.”
Late in the Q&A, Kastelein addressed data previously presented at ACC suggesting slower eGFR decline and nominally fewer renal events over 12 months in Phase 3 studies. He said any improvement in eGFR could be “very clinically relevant,” particularly over long-term treatment horizons, and said the company is consulting nephrologists as it works to publish the findings.
Management said additional details on PREVAIL and related analyses will be shared at the Aug. 5 investor day.
About NewAmsterdam Pharma NASDAQ: NAMS
NewAmsterdam Pharma, Inc is a clinical‐stage biopharmaceutical company focused on discovering and developing novel small‐molecule therapies for cardiometabolic diseases. The company’s research efforts are aimed at addressing key unmet needs in metabolic syndrome, obesity and type 2 diabetes by modulating pathways involved in glucose regulation, energy homeostasis and lipid metabolism.
The company’s development pipeline features multiple small‐molecule candidates at various stages of preclinical and clinical evaluation.
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