Express Oral Alzheimer's Therapy Phase 2 Results Positive, Significantly Improved Biomarker Levels

▎WuXi AppTec Content Team Editor Alzheon announced today that its oral therapy ALZ-801 (valiltramiprosate) for the treatment of patients with early Alzheimer's disease has achieved positive biomarker results in a Phase 2 clinical trial
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After 6 months of treatment, patients with Alzheimer's disease achieved clinically relevant and statistically significant reductions in plasma biomarkers
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The patient also experienced improved memory
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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 process potential
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Mechanism of action studies have demonstrated that ALZ-801 completely inhibits the formation of amyloid oligomers at doses used in Phase 3 clinical trials
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An ongoing Phase 2 clinical biomarker study is evaluating ALZ-801 in patients with early Alzheimer's disease who carry one or two copies of the apolipoprotein ε4 allele
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APOE4 genotype, a major risk factor for Alzheimer's disease after aging, was associated with a seven-fold increase in brain levels of neurotoxic amyloid oligomers
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Image source: 123RF Phase 2 clinical trial results including 80 patients showed that plasma p-tau181 levels were significantly reduced by 29% at week 26 (p=0.
028) in the ALZ-801 group and by 18% at week 13 (p=0.
038)
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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)
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Phosphorylated tau protein (p-tau) levels in plasma and cerebrospinal fluid are sensitive and specific markers of brain damage and neurodegeneration in Alzheimer's disease
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Given the importance of p-tau181 and Aβ42 as core Alzheimer's disease pathological biomarkers, these results support a disease-modifying role for ALZ-801 in Alzheimer's disease
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In addition to biomarker results, the Phase 2 clinical study also included the Rey Auditory Verbal Learning Test (RAVLT) as a secondary endpoint
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Analysis of the RAVLT total memory score (including immediate and delayed recall) showed a significant improvement from baseline to week 26 (p=0.
002)
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In subjects treated with ALZ-801, the most common adverse events were mild nausea, no evidence of angioedema, and no drug-related serious events
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The safety and tolerability profile was consistent with previous data from more than 2,000 patients in the Alzheon safety database
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"These data further support the clinical benefit observed with Alzheon in previous Alzheimer's disease studies
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Combined with a favorable safety profile and absence of angiogenic edema events, these new biomarker data and their association with cognitive benefit The positive correlation further validates the disease process-altering effect of ALZ-801 in Alzheimer's patients," said Alzheon founder, president and CEO Martin Tolar, Ph.
D.
Unlike the slowing down of cognitive decline in patients, ALZ-801-treated subjects showed significant cognitive improvement relative to baseline on memory tests
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"However, some external experts pointed out that although the levels of biomarkers differed significantly, the causality between them and clinical benefit in Alzheimer's patients remains to be verified
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ALZ-801 will be accepted in Phase 3 clinical trials.
For further testing, this clinical trial, funded by US$47 million from the National Institute on Aging (NIA), will enroll patients with early-stage Alzheimer's disease with APOE4/4 genotype
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Combined with the latest biomarkers to track patient benefit, and The ADAS-Cog 13 score, which measures the clinical benefit of patients, was used as the primary clinical endpoint
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Reference: [1] Alzheon Reports Industry-Leading Disease Modifying Effects from Phase 2 Biomarker Trial of Oral Tablet ALZ-801 (Valiltramiprosate) in Patients with Early Alzheimer's Disease.
Retrieved February 8, 2022, from https:// 'Very over sold': Biotech brags about PhII Alzheimer's data, but experts are underwhelmed.
Retrieved February 8 , 2022, from https://endpts.
com/very-over-sold-biotech-brags-about-phii-alzheimers-data-but-experts-are-underwhelmed/Disclaimer: WuXi AppTec content team focuses on global biotech Advances in Medicine and Health Research
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This article is also not a treatment plan recommendation
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