Anxious to hear any updates from Annovis Bio Butanetap phase 3 trial cohorts

[redhawk1]

Just wondering if any of the Annovis Bio cohorts have had any updates from his/her experience in this trial they could share with the rest of the people on this blog. Thank you again to those taking part in this trial and all trials as you are truly at the tip of the spear!

[MBAnderson]

I have been taking it for exactly one month and have seen no benefit.

[redhawk1 in reply to MBAnderson]

Thanks Marc . I know it’s early in the trial for most . . . and, one does not know if on placebo or the real thing. We’re just hanging out here hoping for that sign of efficacy!!’Keep up the good fight!

[jimcaster]

I have been reluctant to say anything because I don't want to taint anyone else's experience or expectations, but I will be going in for my final appointment in July. At times, I have thought maybe I am a little sharper mentally, but I have not seen any dramatic improvements, particularly regarding motor skills. I have communicated privately with others on this site who are also in the trial. I'd love to be corrected, but I am not aware of anyone who has noticed significant improvements. We can't all be getting the placebo. I think Annovis Bio is better at raising money than they are at curing diseases. Again, I hope I am wrong.

[MBAnderson in reply to jimcaster]

Jim, True of every trial so far. (I wouldn’t worry about tainting the process.)

I appreciate your feedback.

Marc

[Parkinsonjisung in reply to jimcaster]

Are you or any of the people you have spoken to any worse?

As far as I understood it, the drug doesn't claim to improve symptoms.

[MBAnderson in reply to Parkinsonjisung]

What's the point - what is it's claim then?

"It was also superior to a placebo at improving cognitive and motor skills in Parkinson’s patients. Researchers determined 10 or 20 mg offered the best overall clinical benefit, leading to significant reductions in disease severity, as assessed by the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS)."

parkinsonsnewstoday.com/new...

[WinnieThePoo in reply to MBAnderson]

You're right Marc. Whilst it would be perfectly legitimate for a drug to focus on preventing progression, without providing immediate symptomatic relief (exanatide?), that requires a much longer trial period. Probably at least 2 years.Annovis clearly anticipated significant symptomatic relief based on their tiny previous trial results and have an expectation of immediate clinical results. And hence opted for a short trial period for their phase 3.

They were not alone in their favorable interpretation of PD outcomes based on a very ambiguous phase 2 result. In particular the reduction in benefit with increased dosage was always a red flag

[jeffreyn in reply to WinnieThePoo]

Slide 16 in this April 2023 presentation has some information on a planned "disease-modifying study".

irpages2.eqs.com/download/c...

[ProudParkie2017]

This is actually my first post here. I am 52 diagnosed 2017, started levodopa February 2022. I started butanetap January of 2023. I tend to get side effects with every drug I take (I tell my Neuro that I’m the side effect queen 😜). I had horrible nausea with neuraly and with this have had none so I was pretty convinced I was on the placebo. A month after I started butanetap I restarted my monthly cycles after having none for two years 🤦🏻‍♀️. Side effect? Or just not officially in menopause? 🤷🏻‍♀️. Around the end of March I noticed an improvement of motor symptoms and increased energy. In the past month I’ve noticed increased dyskinesia during peak levodopa levels (too much dopamine?). I’ve also been eating better, exercising, and have lost 35 pounds. There’sa chance these could be the cause of my improvement. I do know that if they open label extension it, I will be first in line. I feel good. For the first time in several years. My Neuro motor test went from an 18 to below 10. I have an arm swing again. I have No idea if it’s the drug or not but I’m hopeful.

Sorry for the novel as my fist post!!

[redhawk1 in reply to ProudParkie2017]

Hi Em . . . Whatever is the cause for your improvement so glad you are feeling better. I think all of us have “good” days and “bad” days but for me those “good” days are fleeting. Your symptom improvements seem to be lasting. I was in the Roche/Prothena trial for 5 years and although the medication I was taking may have slowed the progression of the PD I never noticed that epiphany of improvement in symptoms as you are.

[tacato]

I’ve been in the study for 4 months. Without hesitation I can say I feel worse now than before I started the study. Hopefully I am on placebo.

[1953bullard]

I’ve been on it or the placebo since January. Some times I think I have less brain fog. I am definitely stronger but that could be cumulative from working out with my trainer. My motor symptoms and balance seem about the same. I don’t think I’ve had any progression though

[jimcaster in reply to 1953bullard]

I think our experiences are very similar. One thing I have learned is that trials need to take quite a bit of time because the disease progresses so slowly that it's almost impossible to detect any progression after just six or seven months.

[shoreforsure]

I am approaching 3 months and have no changes. I asked the neurologist if he had trial patients with benefits (He probably is not supposed to tell me) and he said no. He also found it a bit odd that 6 months will not show much of a progression change.

[Farooqji]

I haven't heard from anyone about some noticeable improvements with butanetap. The question arises whether the individuals were from mars who were having good results in phase 2

[Xnay in reply to Farooqji]

I am not from Mars

[Farooqji in reply to Xnay]

But you have not shared your experience regarding butanetap

[NextStage]

I started with the Buntanetap study drug 6 weeks ago. I found a right hand typing test to use to measure progress. Before starting the trial I could type 33 words in 90 seconds, doing this in the morning before taking my Sinemet. This morning I could type 39 words in 90 seconds. I am cautiously optimistic about my progress.

[Ctime]

"I am cautiously optimistic about my progress" Agreed

[LeharLover62]

I thought I remembered reading somewhere that this may be a drug that has a few super responders, rather than helping everyone? Does anyone else know?