Does it indicate failure of another clinical trial

[Farooqji]

Annovis blames ‘data cleaning’ efforts for delaying phase 3 Parkinson’s readout

fiercebiotech.com/biotech/a...

[Boscoejean]

What is data cleaning?

[Farooqji in reply to Boscoejean]

from the dictionary:

"Data cleaning is the process of fixing or removing incorrect, corrupted, incorrectly formatted, duplicate, or incomplete data within a dataset."

en.wikipedia.org/wiki/Data_...

[CuriousMe12 in reply to Farooqji]

That's a good description. It's not a good look for the study when they admit to incorrect data collection/recording. Depending on which data items are incorrect, the reason and how easy to rectify it could put the trial in doubt.

It could be nothing like rectifying mis spelled names. Or more serious like rectifying poor results recording.

[b20000 in reply to CuriousMe12]

Incorrect or missing data happens in all studies. I think Annovis leadership underestimated how long it takes to pull in top line results from a larger study. Hopefully results are good.

[CuriousMe12 in reply to b20000]

That's a disturbing acceptance.All data systems I've developed put data accuracy as critical.

If data is incorrectly recorded 1st time who's to say data correction is correctly applied?

[Farooqji]

** ANVS shares fell ~9% in the last 12 months

xm.com/research/markets/all...

[MrColorado]

It doesn’t in any way. It means exactly what the CEO said it means. It will take them longer to clean the data. The timeline Maria gave was very ambitious (1 month) & most Big Pharma companies take months.

The 3rd party company in charge of cleaning the data has not completed it yet. And the data remains blinded which means we don’t know if it will be bad or good yet.

I think the source of your article is biased as well since they have another article that claims Annovis didn’t reach statistical significance in phase 2 despite achieving Statistically Significant Improvements in Speed and Motor Function in PD Patients. That tells me they are misleading at best, disinformation at worst.

[Farooqji in reply to MrColorado]

It will help us if the forum members who are participating in the trial share their experiences here

[WinnieThePoo in reply to Farooqji]

Unfortunately it won't help anyone at all.

[NextStage in reply to Farooqji]

I was in the trial. I don't know if I had the placebo or not. Besides subjectively feeling like I was improving, I also got some objective data. I would periodically do a righthand typing test (all words only use letters that the right hand should be typing) before taking my morning meds. During the first two months taking the trial drug I steadily improved my word count until it matched my left hand, which is unaffected. After the trial stop it has held steady. However, I am a believer in the "No Silver Bullet" and try many things. A bit after stopping the trial I started doing Intermittent Fasting. I also increased usage my vibrating gloves following PD Buzzboards design. Finally, in the last several weeks I have started sprouting Broccoli seeds and eating the sprouts every day. So, I'm not sure how much of the continuation of the effect after stopping the drug could be attributed to a permanent (semi-permanent?) change in my condition due to the drug versus other interventions having a positive effect.

Hopefully this post provides hope for those on this forum reading it.

[emstadler71 in reply to Farooqji]

I have posted here before about my results. I have no idea if I was on the placebo or the actual trial drug but I did see a huge benefit. The biggest benefit I saw was my arm swing came back. Now I am at six months since I ended the trial and I still have an arm swing. I have my fingers crossed that this will go through. I’d really like to go back on it because my tremor has increased since going off. I do tend to be the queen of side effects with almost any medication, and this Trial had very minimal side effects for me. The only weird thing I would say is that I had been two years without having a monthly cycle. My doctor told me I was in perimenopause and one month after starting the trial drug. I started my cycle again and had a cycle every month until my trial ended. I even saw the doctor and my bloodwork and hormone results showed that I was no longer in perimenopause and I was actually pre-menopause. 🤷‍♀️

[Farooqji in reply to emstadler71]

Arm swing restoration is a huge improvement. Wish that it's due to buntanetape

[peminc in reply to Farooqji]

I don' t believe that getting a few patients responses will help in any way. IMO, those who are on placebo and are disappointed are most likely to air their dissatisfaction, and also we cannot be assured that anyone making negative or positive statements is in fact an authentic trial participant and not a market participant who has shorted the stock or is long the stock, respectively. As a case in point, years ago my wife was in a highly successful trial and was not on the placebo arm. It was apparent to her the medication was working, and she had no interest in going online. Had she been on the placebo arm and disappointed with her experience, she may well have gone online to see what is going on.

[NextStage in reply to MrColorado]

I was in the trial and my trial coordinator mentioned in passing one time that someone from Annovis Bio or a third party company had come to audit her conducting the trial. She said she had gotten in trouble because for one task she had written down the end time versus the beginning time. This was a task that took about 2 minutes. The whole trial that day was a 3 hour affair. To me the difference didn't seem important, but maybe it's stuff like this that they are handling during data cleaning.

[peminc in reply to NextStage]

Glad to hear that the trial protocols are rigorously observed.

[Pegcity]

I received this email on Jan 22

Dear Friends,

We know that you have all been waiting for word of our Phase III study results by the end of this month. Data preparation is still in progress, so are not able to analyze the study data this week as we had planned. The announcement of study results will be delayed.

Thank you for your patience as we work to get everything ready for analysis. We will provide further updates as we have them, including our plan for additional studies.

Kind regards,

Sarah MacCallum

Senior Clinical Project Manager, Clinical Operations

[Ctime]

My guess is we are seeing some effect of the speed that trial was conducted as well as the short duration. There may be some really obvious outlier points in the data, either individual records or trial participants that they want to investigate to make sure they are valid. Outliers would show in the blinded data.

To me, it is disappointing that objective measures like data from wearables or even like Next Stage, a basic typing test are not included in all studies even if they are only experimental endpoints. Similarly, I am surprised that PPMI is not adding to their dataset with these objective measures.

I find my ability to perform the physical UDPRS actions very dependent on exercise, diet, mood, sleep etc. So a once a month assessment seems so random to me. I understand that the volume of data is supposed to smooth this out but it does seem that the chance of finding small signals (modest drug benefit or benefit in subpopulations) is reduced with all the subjective noise.

[Farooqji]

Topline buntanetap trial data in early-stage Parkinson’s due ‘soon

parkinsonsnewstoday.com/new...