Alzheon Initiates Long-Term Extension of ALZ-801/Valiltramiprosate Phase 3 Trial and 52-Week Phase 2 Biomarker Trial Extension for Early Alzheimer's Patients

Alzheon, a biopharmaceutical firm, has initiated a long-term extension study for patients who have completed the APOLLOE4 Phase 3 trial of ALZ-801/valiltramiprosate, an oral drug for early Alzheimer's disease (AD). The extension study will further examine the drug's impact on the disease's progression and gather additional safety and tolerability data. Additionally, subjects from the Phase 2 biomarker trial have been offered a 52-week extension to aid in the expansion of biomarker-guided treatment to a larger portion of AD patients with the APOE4 gene.

ALZ-801 is a promising therapy in Phase 3 development, designed to treat early AD by targeting neurotoxic soluble beta amyloid oligomers. It has shown potential efficacy and safety, particularly for patients with the APOE4/4 genotype, who are at a higher risk for AD. The pivotal APOLLOE4 trial is fully enrolled and is expected to release its topline data in 2024.

The extension study will assess the drug's effects on cognition, function, daily activities, and neuropsychiatric symptoms, along with the impact on biomarkers that are sensitive indicators of AD progression and neuroinflammation. Alzheon's Chief Medical Officer, Susan Abushakra, emphasized the company's commitment to patient-centric treatment, highlighting the importance of continued access to ALZ-801 for those suffering from AD.

The Phase 2 biomarker trial, which focuses on patients with the APOE4/4 or APOE3/4 genotype, has shown significant reduction in plasma p-tau181 levels, a key indicator of neurodegeneration, after 104 weeks of treatment. The trial's success has prompted an additional 52-week extension to further investigate the correlation between biomarkers and disease progression, as well as the long-term effects of ALZ-801.

Alzheon's Chief Development Officer, Aidan Power, and Chief Scientific Officer, John Hey, both expressed optimism about the upcoming data from the APOLLOE4 trial and the potential of ALZ-801 to modify the disease's course. The company's approach to precision medicine, focusing on high-risk patients and incorporating advanced biomarkers, is expected to yield valuable insights into the treatment of Alzheimer's disease.

ALZ-801 is positioned as a first-in-class oral therapy for early AD, with the APOLLOE4 trial supported by a substantial grant from the National Institute on Aging. Alzheon's dedication to developing innovative treatments for neurodegenerative disorders is evident through its broad portfolio of product candidates and diagnostic assays, all aimed at directly addressing the underlying pathology of these conditions.