Annovis Bio Shows Alzheimer’s Reversal in Humans in Phase II Study

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aequalsz
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Annovis Bio Shows Alzheimer’s Reversal in Humans in Phase II Study

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https://www.biospace.com/article/annovi ... -ii-study/

Haven't kept up - not sure if this has been introduced.

A=Z
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NF52
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Re: Annovis Bio Shows Alzheimer’s Reversal in Humans in Phase II Study

Post by NF52 »

aequalsz wrote:https://www.biospace.com/article/annovi ... -ii-study/

Haven't kept up - not sure if this has been introduced.

A=Z
4/4
Hi A=Z! Glad to have you post this, since I saw it a few days ago and thought "hmm..." Here's the good news:
Preliminary data from Annovis Bio’s Phase II study of ANVS401 shows significant cognitive improvements in Alzheimer’s patients after only one month of treatment.
The study involved patients with mild to moderate Alzheimer’s disease. After 25 days, patients showed a 4.4-point improvement in cognition compared to baseline and a 3.3-point improvement compared to placebo, using the 70-point, 11 item Alzheimer’s Disease Assessment Scale (ADAS-11).
Here's the cautionary news:
Annovis Bio’s data was based on assessments of 14 patients with Alzheimer’s disease and 14 with Parkinson’s disease. As data comes in from the remaining 40 trial participants, it is expected to confirm these results and shed light on any subsequent improvements.
This is VERY preliminary data on a VERY small number of patients.

In fact, this study's Primary Outcome listed in the materials submitted to the NIH database [https://clinicaltrials.gov/ct2/show/NCT ... w=2&rank=1] was to look at adverse effects (i.e. safety) and the secondary outcome was to look at plasma concentrations in the blood (efficacy). This is typical of Phase II studies to focus first on safety and efficacy. They included five "other outcomes", only one of which was the ADAS-11. That suggests that the participants didn't change significantly on the MMSE, the CDR, and the Coding test of the WAIS (a speed and processing test from the Weschler Adult Intelligence Scale).Doing better on one assessment suggests it might be chance, since they didn't (and probably couldn't) say it was statistically significant.

Here's a brief summary of ANVS-401, which is referred to as "Posiphen" in the Clinical Trials.gove database by Alz Forum: Posiphen.
Posiphen, also known as ANVS-401, is the pure (+) enantiomer of phenserine... Both Posiphen and phenserine reduce production of amyloid precursor protein by blocking translation of its mRNA. Phenserine also inhibits acetylcholinesterase, while Posiphen does not. It is dosed by mouth and enters the brain.

Posiphen acts on iron-response element sequences in the 5' untranslated region of APP mRNA to inhibit protein synthesis. It reduced APP and Aβ in neuronal cultures and brains of wild-type and AD transgenic mice (Lahiri et al., 2007; Marutle et al., 2007). The drug was reported to be neuroprotective and neurotrophic in AD mouse models (Lilja et al., 2013; Lilja et al., 2013), and to normalize memory impairment, learning, and synaptic function (Teich et al., 2018).

Posiphen reportedly also blocks translation of α-synuclein mRNA, implying potential application in Parkinson’s disease (Rogers et al., 2011; Mikkilineni et al., 2012; Yu et al., 2013). The compound reduced α-synuclein expression in brain and gut, and improved intestinal function in the A53T α-synuclein transgenic mouse model of PD (Kuo et al., 2019).
It sounds intriguing and any novel target is exciting. Let's hope the early results are confirmed in the group of 40 and later in many more people!
4/4 and still an optimist!
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