On September 21, 2023, NewAmsterdam Pharma Company N.V. (the “Company”) issued a press release reporting initial data from its Phase 2a clinical trial evaluating obicetrapib in patients with early Alzheimer’s disease (“AD”) and at least one copy of the apolipoprotein E4 mutation (“ApoE4”).
The open-label and single-arm trial was designed to assess the pharmacodynamics, pharmacokinetics, safety and tolerability of obicetrapib 10 mg in early AD patients carrying at least one copy of ApoE4. A total of 13 patients were given 10 mg obicetrapib and followed for 24 weeks. In the trial, the Company observed reductions in the levels of 24- and 27-hydrocholestrol of 11% and 12%, respectively, in the cerebrospinal fluid (“CSF”). In addition, an increase of 8% in the Aß42/40 ratio in patient’s plasma was observed and pTau181 levels were observed to be stable. Overall, obicetrapib was observed to be well-tolerated. No serious adverse events (“AEs”) were reported, nor were any AEs considered to be related to study drug.
Increases in 24- and 27-hydroxycholesterol over time have been observed to lead to a rise in cognitive and related functional impairment. As such, the Company believes reductions of these oxysterols in the CSF may indicate improved cholesterol metabolism in the brain and may lead to improved cognitive function. In addition, the Phase 2a trial assessed the Aß42/40 ratio and plasma pTau181, also believed to be biomarkers of AD, with lower levels of Aß42/40 and increased levels of pTau181 having been associated with a greater risk of AD. This trial builds on observations from the Company’s preclinical studies and third-party genetic studies that inhibiting cholesteryl ester transfer protein may protect against ApoE4-associated AD risk by preventing the accumulation of amyloid plaque in the brain through improved cholesterol metabolism and, as a result, potentially slow disease progression.
The Company anticipates sharing the full results of this Phase 2a clinical trial in a forthcoming publication or in a presentation at an upcoming medical meeting and plans to seek feedback from the U.S. Food and Drug Administration, to inform the potential further development of obicetrapib for the treatment of AD.
A copy of the press release is furnished as Exhibit 99.1 hereto. This Report on Form 6-K (excluding Exhibit 99.1) shall be deemed to be incorporated by reference into the Company’s registration statement on Form S-8 (File No. 333-271019).
Forward-Looking Statements
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