Jul. 14 at 3:51 AM
This granulated question regarding a single measurement about ADAS-Cog improvement over placebo at 3 months for
$ANVS can not be satisfactorily answered in isolation or in comparison with CGTX or AVXL. Each of these companies had different trial designs.
IMO, after knowing what I know about Dr. Maccecchini I would say that it is likely her data is non-robust ... as it always had been.
Additionally, the Alzheimer's Disease Scale-Cognitive sub scale (ADAS-Cog) has two main versions: the original ADAS-Cog 11 and the expanded ADAS-Cog 13. The ADAS-Cog 11 has 11 items, while the ADAS-Cog 13 includes two additional items: a number cancellation task and a delayed verbal recall task, for a total of 13 items.
I have discussed Annovis Bio's studies with different people and groups. I was always the outlier in my group as no one saw any value in Dr. Maccecchini's studies. Their opinion was that they were poorly constructed and were not robust nor investable. This is supported by the lack of Institutional investors.
Understanding this science to a deep degree is not my strength. I rely on others for this. I trust myself less now regarding judging someone's character after my experiences with Dr. Maccecchini.
I'm going to take a leap of faith and assume that @moneyonthebrain is asking his/her question in earnest. S/he has asked me this question before and I have seen this image promoted as a strength of Annovis Bio's data on some of his/her other posts. I am assuming that s/he has a background in science.
My goal is to share a viewpoint which is likely different than his/her's. This viewpoint (below) of the data is not mine, but someone who I consider a friend who was kind enough to take a moment of his time to share his impressions. Thank you : )
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To start, the trial length was only 3 months, in which placebo effect is still in play (as is even evidenced by the relatively large placebo improvement). Combined AD cohort (202 patients) did not show statistically significant improvement. It was only after narrowing down to mild-only patients did the company see efficacy in ADAS-COG11 against placebo, which was not pre-specified.
From all sourceable material, the most promising sign of efficacy comes from the 29 Apr 2024 PR, specifically Table 1:
https://www.annovisbio.com/press-release/annovis-bio-announces-statistically-significant-phase-ii-iii-data-in-patients-with-early-alzheimers-disease
Distribution of responders and non-responders per cohort definitely allude to the drug providing real benefit to patient. How great that benefit is could be decided by a longer trial.
What the company needs now is a large placebo trial with pre-specified patient populations spanning 48-76 weeks - unless of course ANVS believes they can only provide symptomatic relief, in which case 12-24 weeks is likely adequate.
Comparisons between ANVS and its competitors should be taken with extreme caution at this stage, given the data provided came from a poor clinical design featuring unproven Alzheimer’s patients, low N, and lack of pre-specified patient populations.
Finally, I’d like to point out that the AVXL metric provided is not correct.
If more evidence is required of the messy outcome for the clinical design, I’d look at the ANVS investor slide deck, slide 13 in which the company had to compare all ADAS-COG11 results to baseline instead of placebo because placebo improved an astronomical amount.
Placebo outperformed 7.5mg, was nearly equal to 30mg, and was equal to pooled doses. The only cohort that performed well was the 15mg which seems fishy.
NFL - a marker of degeneration performed very well
I see from slide 19 they are looking to run an 18 month trial with two primary readouts, one at 6 months (to assess whether the drug could be symptomatic approved) and the other at 18 months, to see if it can be approved as a disease modifier.
This is the data that needs to be seen and compared.
I do see the N for each arm (placebo or 30mg) is only 380 each. They may have some issues there if the drop out is strong.
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We're lucky to have Stocktwits users who are able to offer insights at this level.
We don't all have to agree on things or how we interpreter data.
However, when we see something that's fishy ... or, if we know it stinks we should share this with each other. I finally understand Dr. Maccecchini based on what she has disclosed to me on why her data is weak at best when the data is not narrated by her, but by others on her staff and Board.
I get the sense that no one cares ... so I won't go into it *
I am also not going to delve into CGTX for the sake of keeping my post short.
Apologies moneyonthebrain for taking so long to get back to your question. I saw your question, but just felt like any answer from me would be inadequate. Cheers!