NewAmsterdam Pharma Secures US Patent for Obicetrapib

NewAmsterdam Pharma Company N.V., a biopharmaceutical firm developing non-statin oral therapies for cardiovascular disease (CVD) patients with elevated low-density lipoprotein cholesterol (LDL-C), has announced that the United States Patent and Trademark Office (USPTO) has issued a new patent, U.S. Patent No. 12,006,305. This patent, titled “Salts of Obicetrapib and Processes for their Manufacture and Intermediates Thereof,” provides intellectual property protection for obicetrapib until July 2043. The patent covers amorphous obicetrapib hemicalcium, the solid form intended for use in the company's products, which will be listed in the FDA’s “Orange Book” if these products gain approval.

The newly granted patent extends the intellectual property protection for obicetrapib by more than nine years beyond the expiration of the previous second-generation patent, which was set to expire in 2034. Michael Davidson, M.D., CEO of NewAmsterdam, emphasized the significance of this extended patent protection, noting the ongoing need for effective, safe, and oral LDL-lowering therapies. Davidson highlighted that robust patent protection allows the company to continue its pivotal Phase 3 trials and benefit from the innovation behind obicetrapib for years following potential FDA approval.

Obicetrapib is an innovative oral CETP inhibitor designed to address the limitations of current LDL-lowering treatments. In NewAmsterdam's Phase 2 trials, which included studies named ROSE2, TULIP, ROSE, and OCEAN, obicetrapib demonstrated significant LDL-C lowering with a side effect profile similar to placebo. The company is currently conducting two Phase 3 pivotal trials, BROADWAY and BROOKLYN, which are assessing obicetrapib as a monotherapy alongside maximally tolerated lipid-lowering therapies. Another Phase 3 trial, TANDEM, is evaluating a fixed-dose combination of obicetrapib and ezetimibe. Patient enrollment for these trials began in 2022 and 2024, with completions in BROOKLYN and BROADWAY achieved in 2023.

Additionally, NewAmsterdam commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022. This trial aims to evaluate the potential of obicetrapib to reduce major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and non-elective coronary revascularization. The company successfully enrolled over 9,500 patients for PREVAIL by April 2024.

NewAmsterdam Pharma, traded on Nasdaq under the ticker NAMS, aims to address a significant unmet need in the treatment of metabolic diseases, particularly for patients who have not responded well to existing therapies. The company's focus is on developing safe, effective, and well-tolerated LDL-lowering therapies. In its Phase 3 studies, NewAmsterdam is investigating obicetrapib, both as a standalone treatment and in combination with ezetimibe, to provide an additional LDL-C lowering option for patients at risk of CVD.

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