Potential Treatment, ALZ-801, Shows Efficacy in Early Alzheimer’s Patients with Risk Gene

Potential Treatment, ALZ-801, Shows Efficacy in Early Alzheimer’s Patients with Risk Gene
ALZ-801 may be a safe and effective treatment for Alzheimer’s patients with mild disease who carry two copies of the APOE4/4 gene, results of a clinical program indicate. The results are being disclosed in four presentations by the drug's developer, Alzheon, at the 13th International Conference on Alzheimer’s and Parkinson’s Disease, taking place March 29–April 2 in Vienna. ALZ-801 and its active molecule, tramiprosate, are designed to inhibit the toxic aggregation and accumulation of beta-amyloid plaque between nerve cells, a hallmark of Alzheimer’s disease, to protect neurons. “We are pioneering a precision medicine approach to Alzheimer’s disease with our pivotal program for ALZ-801, by focusing on a well-recognized, genetically defined subset of Alzheimer’s patients with the APOE4 [gene] and by targeting patients at an early point in their disease progression, who have shown the greatest response to our lead molecule,” Martin Tolar, MD, PhD, and Alzheon’s founder, president, and CEO, said in a news release. One presentation, “ALZ-801 Brain Penetration, PK/PD Analyses And Clinical Dose Projection Form Basis For Confirmatory Phase 3 Study In Alzheimer’s Disease,” showed that in Phase 1b studies with healthy elderly volunteers, ALZ-801 (265 mg tablet, twice-daily) had an improved rate of drug response and elimination from the body. Compared to previous studies of oral tramiprosate, ALZ-801 was associated with fewer gastrointestinal side effects (such as nausea and vomiting). Alzheon also presented new data on the effect of tramiprosate in a subset of patients from Phase 3 studies that involved more than 2,000 people. This group of mild Alzheimer’s patients had two copies of the gene APOE4/4 (homozygous patients),
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