Alzheon Initiates Long-Term Extension for ALZ-801/Valiltramiprosate in Early Alzheimer’s Patients

Alzheon, Inc., a biopharmaceutical firm focusing on Alzheimer’s disease and other neurodegenerative conditions, has initiated a long-term extension study for participants who have completed the APOLLOE4 Phase 3 trial. This follows the completion of 78 weeks of treatment with the ALZ-801/valiltramiprosate oral tablet. The extension aims to further investigate the drug's impact on disease progression and to gather more data on its safety and tolerability.

The ALZ-801/valiltramiprosate is an experimental oral therapy designed to modify the disease's course in the early stages of Alzheimer’s. It has demonstrated the ability to halt the formation of harmful soluble beta amyloid oligomers at the dosage used in Phase 3 trials. The medication has shown promise in clinical efficacy and safety, particularly among patients who carry two copies of the apolipoprotein ε4 allele (APOE4/4 homozygotes), a high-risk group for Alzheimer’s.

The pivotal APOLLOE4 Phase 3 trial is fully enrolled and is expected to release its primary data in the third quarter of 2024. The study's main goal is to measure changes in cognition using the Alzheimer's Disease Assessment Scale – cognitive subscale (ADAS-cog). It also includes secondary endpoints that assess functionality, daily living capabilities, and neuropsychiatric symptoms.

Alzheon's Chief Medical Officer, Susan Abushakra, MD, emphasized the company's commitment to patient-centric research and the importance of offering continued treatment options to those who have participated in the trials. The extension study will treat eligible participants with ALZ-801 for an additional 52 weeks, followed by a safety check.

Furthermore, subjects from the Phase 2 biomarker trial, who have completed 156 weeks of treatment, are being offered a 52-week extension. This is to support the expansion of the biomarker-enabled indication to encompass two-thirds of all Alzheimer’s patients with the APOE4 gene.

The Phase 2 trial, which included patients with the APOE4/4 or APOE3/4 genotype and positive amyloid and tau biomarkers in cerebrospinal fluid, showed a significant reduction in plasma p-tau181 levels, a key indicator of brain neurodegeneration. The trial's extension will assess additional plasma biomarkers, hippocampal volume, cortical thickness, and cognitive effects.

Alzheon's Chief Scientific Officer, John Hey, PhD, highlighted the significance of the Phase 2 trial's results and the potential for the extension to provide valuable insights into Alzheimer’s disease progression and the effects of ALZ-801.

The company's lead candidate, ALZ-801, is in the final stages of Phase 3 development and is being studied for its potential as a disease-modifying treatment for Alzheimer’s. Alzheon is dedicated to precision medicine, utilizing genetic and biomarker information to develop impactful therapies for neurodegenerative diseases.