April 16, 2024

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Alzheon Oral Drug for Alzheimer’s disease Phase 2 Results Positively

Alzheon Oral Drug for Alzheimer’s disease Phase 2 Results Positively

Alzheon Oral Drug for Alzheimer’s disease Phase 2 Results Positively, Significantly Improve Biomarker Levels

Alzheon announced on February 08 that its oral therapy ALZ-801 (valiltramiprosate) for the treatment of patients with early-stage Alzheimer’s disease has achieved positive biomarker results in a Phase 2 clinical trial.

After 6 months of treatment, patients with Alzheimer’s disease achieved clinically relevant and statistically significant reductions in plasma biomarkers.

The patient also experienced improved memory.

Alzheon Oral Drug for Alzheimer's disease Phase 2 Results Positively

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.

Mechanism of action studies have demonstrated that ALZ-801 completely inhibits the formation of amyloid oligomers at doses used in Phase 3 clinical trials.

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.

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.

Results of a phase 2 clinical trial including 80 patients showed that plasma p-tau181 levels were significantly reduced by 29% (p=0.028) at week 26 and 18% at 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 neurodegeneration in Alzheimer’s disease.

Given the importance of p-tau181 and Aβ42 as core Alzheimer’s disease pathological biomarkers, these results support a disease-modifying role of ALZ-801 in Alzheimer’s disease.

In addition to biomarker results, the Phase 2 clinical study also included the Rey Auditory Verbal Learning Test (RAVLT) as a secondary endpoint. Analysis of the RAVLT total memory score (including immediate and delayed recall) showed significant improvement from baseline to week 26 (p=0.002).

In subjects treated with ALZ-801, the most common adverse events were mild nausea, no evidence of angioedema, and no drug-related serious events. The safety and tolerability profile was consistent with previous data from more than 2,000 patients in the Alzheon safety database.

“These data further support the clinical benefit observed with Alzheon in previous Alzheimer’s disease studies. 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 patients with Alzheimer’s disease,” said Alzheon founder, president and CEO Martin Tolar, Ph.D. The slowed down patients differed from cognitive decline, with ALZ-801-treated subjects showing significant cognitive improvements relative to baseline on memory tests.”

However, some outside experts pointed out that although the levels of biomarkers are significantly different, the causality between them and the clinical benefit of Alzheimer’s patients remains to be verified.

ALZ-801 will be further tested in a Phase 3 clinical trial, funded by the National Institute on Aging (NIA) of $47 million, to enroll patients with early-stage Alzheimer’s disease of the APOE4/4 genotype.

And combined with the latest biomarkers to track patient benefit, and use ADAS-Cog 13 score to measure patient clinical benefit as the primary clinical endpoint.

Alzheon Oral Drug for Alzheimer’s disease Phase 2 Results Positively

(source:internet, reference only)

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