Dutch late-stage clinical biopharma company, New Amsterdam, has unveiled positive topline data from the company’s Phase III TANDEM trial examining its combination solution obicetrapib, to cut cholesterol.
The combination treatment is designed for patients living with heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease (ASCVD).
The Netherlands-based company has been working to develop oral, non-statin medicines for patients at risk of cardiovascular disease (CVD) with elevated low-density lipoprotein cholesterol (LDL-C), for whom existing therapies are not working.
Results from the TANDEM trial (NCT06005597) will be used to support regulatory and approval filings for the 10 mg obicetrapib and 10 mg ezetimibe fixed-dose combination treatment for patients already using maximally tolerated lipid-lowering therapy that has yet to see results.
Results found that the trial met both of its co-primary endpoints, measured as a change in baseline LDL-C, compared with the monotherapy arm after 84 days and obicetrapib 10 mg compared to placebo after the same period. The obicetrapib-ezetimibe fixed dose combination achieved an LS mean reduction of 48.6%. The fixed-dose combination of obicetrapib and ezetimibe was observed to be well tolerated, with safety results comparable to a placebo.
Michael Davidson, CEO of New Amsterdam, said: “We expect these promising results will support our regulatory filings globally and they reinforce our belief that, if approved, obicetrapib in combination with ezetimibe will potentially offer a simple, once-daily treatment capable of significantly reducing LDL-C and improving cardiovascular outcomes.
“After the BROOKLYN trial’s successful readout in July and the additional safety and efficacy data released this week, we strongly believe that obicetrapib as a monotherapy or in a fixed-dose combination with ezetimibe has the potential to help patients achieve LDL-C targets.”
The Phase III trial was a randomised, double-blind, four-arm, placebo-controlled multicenter study conducted at multiple sites across the United States, with 407 patients. It comes as part of a selection of trials being run by the company. Among the TANDEM and BROOKLYN trials, the company is still expecting results from its BROADWAY and PREVAIL trials.
Elsewhere in the field of cardiovascular disease management, Silence Therapeutics has reported positive topline data from the multiple-dose part of the Phase I APOLLO clinical trial of Zerlasiran to treat atherosclerotic cardiovascular disease.
