New Amsterdam Pharma’s obicetrapib has exceeded company expectations in the Phase III BROADWAY trial in adult patients with atherosclerotic cardiovascular disease, with the company now seeking approval for the therapy.
The Phase III trial (NCT05142722) sought to establish the efficacy and safety of obicetrapib in patients living with a cardiovascular disease whose levels of low-density lipoprotein cholesterol (LDL-C) are not controlled despite being on lipid-lowering therapy.
The BROOKLYN trial met its primary endpoint, achieving a mean LDL-C reduction of 36.3% compared to placebo at day 84. The reduction was sustained at day 365 with a mean LDL-C reduction of 41.5%. The company observed reductions in other biomarkers, including high-density lipoprotein cholesterol (HDL-C), non-HDL-C, lipoprotein(a) (Lp(a)), and apolipoprotein B (ApoB).
Results also found that the treatment’s safety and tolerability exceeded New Amsterdam’s expectations, with the company noting a difference in major adverse cardiovascular events after one year of treatment.
The company’s stock price soared by 38.4% after the news was announced, from a market close of $18.52 on 9 December to a high of $25.64 today (10 December). The company has a market cap of $2.24bn.
The 52-week global Phase III trial evaluated 10mg of obicetrapib compared to placebo with the primary endpoint measured as a reduction of LDL-C from baseline to day 84.
Michael Davidson, chief executive officer of NewAmsterdam, said: “We initiated four Phase III trials with obicetrapib in December 2021, with the hope that obicetrapib would become the therapeutic option of choice to add to statin therapy to further reduce cardiovascular risk.
“We have observed obicetrapib, an oral, once-a-day, low-dose tablet, to be clinically differentiated from other lipid-lowering therapies by lowering Lp(a) and small LDL-particles as well as potentially improving glycemic measures that are linked to high cardiovascular risk. Although exploratory at this point, the difference in major adverse cardiovascular events at one year in BROADWAY supports our belief that obicetrapib could provide greater than expected cardiovascular risk reductions through mechanisms beyond LDL-C lowering.”
Previously the Dutch biopharma saw success in its parallel Phase III TANDEM trial examining its combination solution obicetrapib, to cut cholesterol (NCT06005597). In 2025, the company will present additional BROADWAY and TANDEM data at upcoming scientific sessions and will meet with regulatory authorities as it looks to gain approval for its LDL-C lowering therapy.
Elsewhere in the cardiovascular space, medical device giant Edwards Lifesciences has said patients are experiencing “outstanding one-year outcomes” and lower rates of mortality after treatment with its SAPIEN 3 RESILIA heart valve.
