NewAmsterdam Pharma Announces Initial Data from Phase 2a Clinical Trial Evaluating Obicetrapib in Patients with Early Alzheimer’s Disease Who Carry an ApoE4 Mutation - Seite 2

Initial Data from the Phase 2a Alzheimer’s Trial

“We are encouraged by our initial data, in which we observed reductions in CSF levels of 24- and 27-hydroxycholesterol in the 13 patients treated in the trial. We believe increased CSF levels of these oxysterols may be linked to neuroinflammation and Alzheimer’s pathology,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “We are particularly pleased that this observed reduction in 24- and 27-hydroxycholesterol was paired with an eight percent improvement in the Aβ42/40 ratio. 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 characterize its potential for AD in an efficient, cost-effective manner through our ongoing clinical trials.”

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. NewAmsterdam observed reductions in the levels of 24- and 27-hydroxycholestrol of 11% and 12%, respectively, in the CSF. In addition, an increase of 8% in the Aβ42/40 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 the study drug.

“Together, we believe these observations suggest that potent CETP inhibition may offer a novel approach to reducing the risk of AD in ApoE4 carriers. In this small trial, treatment with obicetrapib was observed to reduce levels of 24- and 27-hydrocholestrol and increase the ratio of Aβ42/40 in plasma, supporting our belief that improved brain cholesterol metabolism correlates with removal of amyloid beta peptides which ultimately might lead to improved cognition,” said John Kastelein, M.D., Ph.D., FESC, Chief Scientific Officer of NewAmsterdam.

NewAmsterdam 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.