NewAmsterdam is singing data from its Broadway heart disease trial, hailing another phase 3 win for its cholesterol-busting candidate. Having struggled to wow investors with earlier data, the biotech sweetened its latest pitch with early suggestions that the molecule improves cardiovascular outcomes.
Broadway is one of three studies NewAmsterdam ran to support regulatory filings for obicetrapib in the reduction of LDL cholesterol. The biotech reported a win for its first monotherapy trial, Brooklyn, in July and racked up a victory for a fixed-dose combination based on obicetrapib last month. NewAmsterdam’s stock fell in the aftermath of both readouts despite the trials hitting their primary endpoints.
This time, the biotech’s stock climbed more than 40% to around $26 in premarket trading. The different reaction to the new data, which sent the share price to a new high, may reflect nuggets of cardiovascular outcomes results that NewAmsterdam included in its readout on the CETP inhibitor.
After one year, the biotech saw a 21% drop in major adverse cardiovascular events (MACE) in people on obicetrapib in an exploratory analysis. William Blair analysts said in a note to investors that the result “meaningfully exceeds our expectations,” adding that the level of benefit increases their confidence in the ability of obicetrapib to hit the primary endpoint in an ongoing cardiovascular outcomes trial.
NewAmsterdam linked obicetrapib to lower rates of all-cause mortality compared to placebo, at 1.1% versus 1.4%, respectively, and a MACE composite, at 4.2% versus 5.2%. Obicetrapib had a slight advantage on coronary heart death, 0.5% versus 0.6% for placebo.
The hazard ratios are around 0.8 for each of those three assessments, a result that favors obicetrapib, but the 95% confidence intervals are so wide the analysis cannot exclude the possibility that placebo will beat obicetrapib. Nothing can be concluded from the data but improved cardiovascular outcomes are the great hope for NewAmsterdam investors and the analysis is a positive early signal.
Other Broadway findings echo data from earlier trials. Like Brooklyn, Broadway tested obicetrapib as a monotherapy. The trials had different inclusion criteria, with Broadway expanding enrollment to include some atherosclerotic cardiovascular disease patients, but both used mean reduction in LDL cholesterol at Day 84 as their primary endpoints.
Almost 1,700 patients received obicetrapib in Broadway. The mean reduction in LDL cholesterol in that cohort was 35%, compared to a 2% dip in the placebo cohort. The 33% placebo-adjusted reduction was big enough for the trial to hit its primary endpoint.
The result is at the low end of the range of reductions seen in other trials of obicetrapib. Across multiple trials, NewAmsterdam has seen reductions in LDL cholesterol of 35% to 40% in patients who receive the drug candidate as a single agent. The biotech tracked a 36.1% reduction in Brooklyn and a 35.5% drop in the monotherapy arm of the fixed-dose combination study.
Obicetrapib delivered a clean safety profile once again. The rates of treatment-emergent adverse events (TRAEs), drug-related TRAEs and TRAEs leading to discontinuation of treatment were numerically higher in the placebo arm than the obicetrapib cohort. The rate of treatment-emergent serious adverse events was also higher in the placebo group, 13.9%, than the obicetrapib arm, 12.5%.
NewAmsterdam plans to meet with regulators to discuss filing for approval. A potential filing for a MACE label will need to wait until the biotech has data from Prevail, a cardiovascular outcomes study of almost 10,000 people that is on track to wrap up late in 2026.