NewAmsterdam's CETP inhibitor meets primary endpoint in Phase 3 trial

NewAmsterdam Pharma has achieved significant progress with its cardiovascular drug obicetrapib, which has shown efficacy in lowering lipoprotein levels that carry cholesterol in the bloodstream. This success marks the third positive outcome for the medication this year. In the latest BROADWAY trial, the drug met its primary goal by significantly reducing low-density lipoprotein (LDL) cholesterol compared to a placebo after 84 days of treatment. The trial yielded a highly significant p-value of less than 0.0001, indicating robust statistical importance.

As a result of these promising findings, NewAmsterdam Pharma's stock, listed as $NAMS, saw an increase of over 30% on Tuesday, reflecting investor confidence in the drug's potential. The company is currently exploring obicetrapib's effects on patients diagnosed with atherosclerotic cardiovascular disease and heterozygous familial hypercholesterolemia. Those treated with the drug experienced a 33% reduction in lipoprotein levels, contrasting with a 3% increase observed in patients given a placebo. Furthermore, there was a reported 21% decrease in major adverse cardiovascular events favoring the drug, highlighting its promise in combating cardiovascular risk.

The discontinuation rate among patients taking obicetrapib was slightly lower at 11.1% compared to 12.4% in the placebo group, suggesting good tolerability of the treatment. Michael Davidson, CEO of NewAmsterdam, emphasized the distinctiveness of obicetrapib as an oral, once-daily, low-dose tablet. He highlighted its capability to reduce Lp(a) and small LDL particles and possibly improve glycemic measures, all of which are linked to elevated cardiovascular risk.

Davidson also mentioned that the company plans to unveil further data from the BROADWAY trial and results from another Phase 3 trial, called TANDEM, at scientific conferences next year. These findings will accompany discussions with regulatory bodies regarding potential filings for therapies designed to lower LDL cholesterol.

Currently, NewAmsterdam is conducting four Phase 3 trials with obicetrapib. Earlier this year, the company shared two sets of data. In November, results from the TANDEM trial revealed that patients who received a combination of obicetrapib and ezetimibe experienced a 49% reduction in LDL cholesterol over 84 days. In contrast, those who took only obicetrapib saw a 32% decrease. In a previous readout from July, obicetrapib was shown to reduce LDL cholesterol by an average of 36.3% compared to placebo after 12 weeks.

Overall, NewAmsterdam Pharma's recent achievements signify a promising advancement in the treatment of cardiovascular conditions related to cholesterol management. With ongoing research and the potential for regulatory approvals, obicetrapib may soon join the arsenal of effective treatments aimed at reducing cardiovascular risk.