NewAmsterdam Pharma Phase 3 Drug Combo Study Hits Main Endpoints

Dow Jones

2024/11/20

By Colin Kellaher

NewAmsterdam Pharma on Wednesday said a late-stage study of its proposed cholesterol drug combination met its key goals, paving the way for the biopharmaceutical company to seek regulatory approval.

NewAmsterdam said the Phase 3 study of a fixed-dose combination of obicetrapib and ezetimibe met all co-primary endpoints in reduction in low-density lipoprotein cholesterol in adults with heterozygous familial hypercholesterolemia and/or atherosclerotic cardiovascular disease or related risk factors.

The Netherlands-based company said the study results will support global regulatory filings for combination in such adults whose LDL-C isn't adequately controlled despite being on maximally tolerated lipid-lowering therapy.

Trading in shares of NewAmsterdam, which closed Tuesday at $23.68, was halted premarket on Wednesday.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

November 20, 2024 07:35 ET (12:35 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.

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