More than 6 million Americans are currently living with Alzheimer’s and about 1 million Americans have Parkinson’s. By 2050, those numbers are expected to grow to 13 million and 2.7 million, respectively.

In patients with just about any kind of neurodegenerative disease, a common feature is the disrupted axonal transport that ultimately causes nerve cell degeneration and nerve cell death — the communication or “streamline” between nerve cells. When that transport is damaged, the nerve cell gets sick and dies. As that degeneration and cell death continues, it can lead to cognitive impairment and movement disorders like those seen in Alzheimer’s and Parkinson’s patients.

In the group receiving ANVS401, ADAS-Cog 11 scores improved statistically significantly by 4.4 points, or about 30%, from baseline (3.3/22% from placebo). For comparison, Biogen Inc. (NASDAQ:BIIB) — whose Alzheimer’s treatment Aduhelm became the first new therapy approved for the disease in nearly 20 years — showed ADAS-Cog11 improvements of just 1.4 points. Moreover, the patients on ANVS401 also showed a 6.6-point, or 23%, improvement from baseline on the WAIS (4.9 from placebo).

In the second Phase 2 trial, 54 Parkinson’s patients were treated with either ANVS401 or a placebo. This time, researchers used the WAIS and the MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) to measure motor function before and after treatment. After 25 days of treatment, patients receiving ANVS401 showed a statistically significant 13.5% improvement on the WAIS and a 2.43-point, about 13%, improvement on the MDS-UPDRS, both compared to baseline (16.5% and 22.8% from placebo respectively).

Those bio samples showed that all three neurotoxic proteins (APP, Tau, and α-Syn) had been reduced in patients taking ANVS401. Moreover, all four inflammatory markers tested were substantially lower in treated patients. Likewise, the two biomarkers used to measure axonal and synaptic dysfunction were reduced.

The reduced levels of all these markers suggest that ANVS401 is effectively disrupting the production of neurotoxic proteins inhibiting the toxic cascade leading to nerve cell death. This, in turn, results in improved scores on cognitive and motor tests proving that the researchers’ hypothesis is correct. Treating neurodegenerative diseases by reducing the toxicity that interferes with axonal transport may be an effective way to improve the lives of millions of patients with neurodegenerative conditions.

Once the final analysis of Phase 2a results is complete, Annovis Bio will request two meetings with the Food and Drug Administration (FDA) to present its results and request approval to move into later-stage trials.
In a presentation at the 14th Clinical Trials on Alzheimer’s Disease Conference in November, Maccecchini said, “Meeting primary endpoints and the reversal of the toxic cascade combined with improvements in cognition and function are the foundation for us to ask the FDA for two meetings — one to move into two Phase 3 clinical trials for Alzheimer’s disease and one to move into two Phase 3 clinical trials for Parkinson’s disease.”

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