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The following post was written and / or published as part of a collaboration between Benzinga’s internal sponsored content team and a Benzinga financial partner.

Annovis Bio inc. (NYSE: ANVS) is a clinical-stage pharmaceutical company focused on drug development for neurodegenerative diseases such as Alzheimer’s disease, Parkinson’s disease and dementia associated with Down syndrome (AD-DS).

More … than 6 million Americans currently living with Alzheimer’s disease and approximately 1 million Americans have Parkinson’s disease. By 2050, these figures are expected to reach 13 million and 2.7 million, respectively.

Both diseases remain incurable and both lack treatment options beyond medications and procedures that target symptoms rather than the root causes of the illnesses. With its flagship compound ANVS401, Annovis Bio hopes to change that. The Pennsylvania-based company completed two Phase 2 clinical trials this year, giving positive results when treating Alzheimer’s and Parkinson’s patients with ANVS401.

How the ANVS401 works

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

ANVS401 was developed based on the hypothesis that high levels of neurotoxic proteins are responsible for this disruption of axonal transport. In a statement on the positive Phase 2 data, Annovis Bio CEO Maria Maccecchini, Ph.D., explained, “When we administer our drug, we expect a reversal of this toxic cascade resulting in efficacy. . “

The compound is an oral lipophilic molecule capable of crossing the blood-brain barrier at high concentrations and, once in the brain, inhibits the production of amyloid precursor protein (APP), Tau and alpha (α) -Synuclein ( α-Syn) – neurotoxic proteins that have been shown to interfere with axonal transport.

While there are other drugs that target neurotoxicity, they usually target a single protein and do so by trying to remove that protein. ANVS401 targets at least three neurotoxic proteins and works by stopping their production before this harmful build-up can occur.

Results of this year’s phase 2 clinical trials

Annovis Bio concluded this year two phase 2 clinical trials, one for Alzheimer’s disease and the other for Parkinson’s disease. In the Alzheimer’s disease trial, 14 patients were treated with either placebo or ANVS401 for 25 days. Patient cognition was measured before and after treatment using the Alzheimer’s Disease Rating Scale — Cognitive Subscale 11 (ADAS-Cog11) and the Alzheimer’s Intelligence Scale. adult Wechsler (WAIS).

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

In the second phase 2 trial, 54 patients with Parkinson’s disease were treated with either ANVS401 or placebo. This time, the 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 improvement of 13.5% on WAIS and a 2.43 point improvement, approximately 13%, on MDS-UPDRS, both over the line. baseline (16.5% and 22.8% of placebo, respectively).

In both trials, researchers collected cerebrospinal fluid and plasma samples from all subjects to measure a range of biomarkers that could tell them if and to what extent ANVS401 actually reduced the toxic cascade responsible for the disruption. axonal transport.

These biological samples showed that all three neurotoxic proteins (APP, Tau and -Syn) were reduced in patients taking ANVS401. In addition, the four inflammatory markers tested were considerably lower in the treated patients. Likewise, the two biomarkers used to measure axonal and synaptic dysfunction were reduced.

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

What’s next for the ANVS401?

Once the final analysis of the Phase 2a results is complete, Annovis Bio will request two meetings with the Food and Drug Administration (FDA) to present its results and seek approval to proceed to later stage trials.
In a presentation at the 14th Alzheimer’s Disease Clinical Trials Conference in November, Maccecchini noted, “The meeting of the primary endpoints and the reversal of the toxic cascade combined with improvements in cognition and function are the basis for which we asked the FDA for two meetings – one to move to two clinical trials. phase 3 for Alzheimer’s disease and one to move up to two Phase 3 clinical trials for Parkinson’s disease.

The foregoing post was written and / or published as part of a collaboration between Benzinga’s internal sponsored content team and a Benzinga financial partner. While the article is not and should not be construed as editorial content, the Sponsored Content team works to ensure that all information contained in it is true and accurate to the best of their knowledge and ability. research. This content is for informational purposes only and is not intended to be investment advice.

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