NewAmsterdam Pharma has reported initial data from a Phase IIa clinical trial of obicetrapib for the treatment of early Alzheimer’s disease (AD).
The single-arm, open-label study assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of the cholesteryl ester transfer protein (CETP) inhibitor obicetrapib in early AD patients carrying at least one copy of apolipoprotein E4 mutation (ApoE4).
A total of 13 patients received 10mg obicetrapib and were followed for 24 weeks.
Cerebrospinal fluid (CSF) was examined to determine the levels of biomarkers including Aβ42/40, and 24 and 27-hydroxycholesterol in the treated patients.
Reductions of 11% and 12% in 24 and 27-hydroxycholesterol levels, respectively, in CSF were observed leading to improvement in cholesterol metabolism and cognitive function in the brain.
The study also observed an 8% increase in the Aβ42/40 ratio, demonstrating an improvement in disease pathology.
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Obicetrapib was found to be well-tolerated with no serious adverse events observed.
NewAmsterdam Pharma CEO Michael Davidson said: “Based on these initial results, we believe obicetrapib could offer a meaningful advancement for a high-risk patient population with limited available treatment options and look forward to working to further characterise its potential for AD in an efficient, cost-effective manner through our ongoing clinical trials.”
NewAmsterdam plans to further develop obicetrapib for the treatment of AD and therefore is seeking feedback from the US Food and Drug Administration.
This year, the company also completed enrolment in Phase III BROADWAY and BROOKLYN trials of obicetrapib to treat high-risk cardiovascular disease patients.
These pivotal trials will assess obicetrapib monotherapy as an adjunct to maximally tolerated lipid-lowering therapies and provide additional LDL-lowering for these patients.