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Alzheon announced the completion of a $50 million Series D funding round that will be used to accelerate its Phase 3 clinical trial of APOLLOE4, an oral study therapy for the treatment of early-stage Alzheimer's disease( alzheimer's disease ( valiltramiprosate ) , as well as potential regulatory applications. At the same time, the company will initiate alz-801 research in other groups of Alzheimer's disease patients, as well as healthy individuals at risk of developing the disease.
ALZ-801 is an oral drug in phase 3 clinical development that blocks the formation of soluble amyloid oligomers associated with cognitive decline in alzheimer's disease patients, with the potential to alter the course of Alzheimer's disease. Mechanism-of-action studies have demonstrated that ALZ-801 can completely inhibit the formation of amyloid oligomers at Phase 3 clinical doses.
In February, the company announced positive biomarker results obtained in phase 2 clinical trials of ALZ-801. After 6 months of treatment, plasma biomarkers in Alzheimer's disease patients achieved a clinically relevant and statistically significant reduction. Patients also receive memory improvement.
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The results of the Phase 2 clinical trial, which included 80 patients, showed a significant 29% reduction in plasma p-tau181 levels at week 26 (p=0.028) and a 18% decrease in week 13 (p=0.038) in the ALZ-801 group. ALZ-801 also significantly reduced the plasma p-tau181/Aβ42 ratio by 30% at week 26 (p=0.022) and by 21% at week 13 (p=0.018). Phosphorylated tau protein (p-tau) levels in plasma and cerebrospinal fluid are sensitive and specific markers of brain damage and neurodegenerative lesions in Alzheimer's disease. Given the importance of p-tau181 and Aβ42 as core Alzheimer's pathological biometric markers, these results support the disease-modifying role of ALZ-801 in Alzheimer's disease.
In addition to biomarker results, this Phase 2 clinical study included the Rey Auditory Speech Learning Test (RAVLT) as a secondary endpoint. Analysis of ravLT total memory scores (including immediate and delayed recall) showed significant improvement from baseline to week 26 (p=0.002).
Martin Tolar, Founder, President and CEO of Alzheon, said: "Alzheon has developed differentiated solutions for the treatment and prevention of Alzheimer's disease. Our small molecule platform targets the same pathway as anti-amyloid antibodies, but produces work upstream, preventing the formation of neurotoxic soluble amyloid oligomers and not disrupting insoluble plaque deposition. This may reduce cerebral edema and microbleeds. This Series D funding and recent clinical trial data will accelerate the development of ALZ-801. It has the potential to be the first oral therapy to delay or even stop disease pathology. ”
Resources:
[1] Alzheon Announces Closing of Oversubscribed $50 Million Series D Financing Round to Accelerate Completion of APOLLOE4 Phase 3 Trial and Expansion of Product Portfolio. Retrieved April 14, 2022, from https://www.businesswire.com/news/home/20220414005067/en
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