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Alzheon today announced the latest positive results
of its investigational drug ALZ-801 (valiltramiprosate) in a Phase 2 biomarker trial.

Data suggest that ALZ-801 improves plasma levels of phosphorylated tau protein (P-tau181), reduces cerebral atrophy, and improves memory function
in patients with early Alzheimer's (AD).

The press release said it was the first Alzheimer's disease drug
to have an effect on reducing brain atrophy.

Alzheimer's disease is a neurodegenerative disease
that is primarily associated with aging.

It is estimated that by the age of 80, one-third of people will be diagnosed with Alzheimer's disease
.

There are currently about 50 million people with Alzheimer's disease worldwide, and as the world's population ages, it is estimated that the number of AD patients will almost triple to 140 million
by 2060.

Genetic and environmental factors influence the occurrence and progression
of Alzheimer's disease.

For example, individuals known to carry the APOE4 gene are at higher risk, with patients with the APOE4/4 or APOE3/4 genotype accounting for 65-70% of the total number of patients, of which patients with APOE4/4 homozygous accounted for about 15%.


Diabetes, chronic inflammation, infections, alcohol use, and mental stress can all contribute to accelerated cognitive decline
.

Toxic amyloid oligomers in nerve cells are thought to be the driving factors contributing to neurodegeneration and cognitive new energy decline in Alzheimer's disease, while plasma levels of the P-tau181 protein are associated
with the progression and exacerbation of Alzheimer's disease.

ALZ-801 is an oral small molecule drug under research as a precursor to high taurine (homotaurine), ALZ-801 can inhibit the formation of neurotoxic amyloid oligomers at a clinical dose of Phase 3, and has the potential
to change the course of Alzheimer's disease.

ALZ-801 received fast-track eligibility
from the U.
S.
FDA in 2017.

In addition to the announced Phase 2 biomarker trial, another Phase 3 trial is underway to test the efficacy and safety
of ALZ-801 in early-stage Alzheimer's disease with APOE4/4 homozygotes.

The main purpose of the announced Phase 2 trial was to examine the effect
of ALZ-801 taken orally twice a day on biomarker levels in patients with early Alzheimer's disease.

Patients have either the APOE4/4 or APOE3/4 genotype
.

A total of 84 patients were enrolled and 75 completed the 52-week trial (mean age 69 years, 52% female).

Data analysis showed that at 52 weeks, ALZ-801 caused a significant decrease of 41% of plasma P-tau181 protein (p=0.
032)
compared with baseline.

Compared with the control group, neuroimaging analysis also showed that the patient's hippocampal volume (Hippocampal Volume) was preserved, suggesting that the drug may have neuroprotective effects on brain structures
.

In addition, at the 3rd, 6th month, and year 1, the patient's memory test was above baseline, which was consistent
with the observed biomarker levels and brain impact results.

In more than 2,000 patients with Alzheimer's disease, ALZ-801 demonstrated good safety and was consistent with previous trials with no angiogenic cerebral edema observed
.

It is worth mentioning that the industry media Endpoints News pointed out that in the 1-year data of the published Phase 2 clinical trial, Alzheon did not publish detailed data on the clinical efficacy of patients, which also makes the results of the ongoing clinical phase 3 trial of this drug more important and exciting
.

Dr Susan Abushakra, Alzheon's Chief Medical Officer, said: "These positive data confirm the potential of ALZ-801, an extension
of what Alzheon scientists have discovered over the past 9 years.

The effect of 12-month drug therapy on plasma P-tau181 protein, coupled with the preservation and clinical stability of hippocampal volume, supports the pharmacological mechanism
of ALZ-801 in anti-amyloid oligomer formation in Alzheimer's disease.

These results support the ability of ALZ-801 to alter the course of the Alzheimer's
disease, which is encouraging.

”

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