Less than a week after announcing a delay in the release of phase lll clinical data, Annovis Bio announced that they are filing for a patent for the use of Buntanetap for mental illness. Meanwhile, the data is still being “cleaned “ from the PD study. I am starting to feel this company is a scam. I doubt the clinical data was positive, hence the “data cleaning.” Now a new patent application for this supposed do it all drug, yet no word on an open label extension for PD.
Buntanetap for Mental Illnesses? - Cure Parkinson's
Buntanetap for Mental Illnesses?
Old wine in new bottle
She has been working on this for more than 10 years. I'm happy to give her a few more weeks, at the very least. [1]
[1] Rogers JT, Mikkilineni S, Cantuti-Castelvetri I, Smith DH, Huang X, Bandyopadhyay S, Cahill CM, Maccecchini ML, Lahiri DK, Greig NH. The alpha-synuclein 5’untranslated region targeted translation blockers: anti-alpha synuclein efficacy of cardiac glycosides and Posiphen. J Neural Transm (Vienna) 2011; 118: 493-507
There is a huge gulf between the "maybe there's a bit of a benefit" damning with faint praise associated with the current trial, and the "really exciting UPDRS scores after no time at all" hype for the previous trial.
The dose variability in the previous trial was a huge red flag. There are a number of other reasons for believing, frustratingly, that this is not "the one". I'd love to be wrong this time, but I hae me doots.
The dose variability was not a red flag. It has what’s called a biphasic dose response curve. levopoda is the same way, so is aspirin
Biphasic?? Are you sure? When 80mg is better than 40 and the same as 5mg.
Yep. Nothing but delays, funding weirdnesses, etc. Every time they say "we may finish in time, or we may be delayed" you already know what it's going to be. If this stuff worked... you'd think we'd know by now. Enough people have tried it.
"Enough people have tried it."
But maybe not for long enough. Maybe 6 months is still too short to clearly see disease modification.
Yes, very shady circumstances. Especially a new patent for mental illness. Where are the studies for treating a variety of mental illnesses with Buntanetap?
John, looking at your profile (it being new) and your only posts being about Buntanetap (all negative) leads me to believe you are part of a coordinate short attack on the stock. This forum is fill of positive sentiment about this drug & company.
Many on this particular thread are obviously investors and do not actually have Parkinson’s disease. Myself included - My mother having Alzhiemer’s is what led me to invest in this company. I have a large investment in the company and if I lose it I see it as a donation to an important cause.
What you (John) are doing here hurts progress and is in my opinion unethical.
I’d like to apologize to those with Parkinson’s on this board as it has been viewed & participated in by investors both bullish on the company (like myself) and some who are betting on its failure (like JohnP65) or have an interest in keeping the price low making it difficult for the company to raise money to continue trials and/or with the intent of possibly allowing big pharma to pick it up for pennies on the dollar.
There is alot of money involved here and I advise those who are a part of this community to keep that in mind as not everyone here has good intentions or even has Parkinson’s.
Interesting! I noticed that your profile has no posts, with only replies defending Buntanetap.
You claim I post only material that is critical of Buntanetap, yet you fail to mention I asked a question about gene therapy. It appears you also “cleaned your data” as to enhance your position.
The motive for my original post is simply that I don’t want to see a PwP, or other chronic diseases/illness, bamboozled by one peddling their snake oil.
Take it for what it is worth, and I hope I am wrong, you have a trial drug claiming to do so much such as treating AD and PD. However, when the rubber hits the road one gets results delayed for “cleaning,” no mention of an open label trial, and a new patent application for a different use.
Whether one is a patient, investor, or both these are red flags.
John, it sounds like you aren’t aware of how the process works or you are spreading misinformation. All trial sites must go through their data and make sure everything is kosher as in no misplaced decimal places, typos, making sure everything put into the computer matches the clinical notes, etc. Once that is completed they lock the data, once the data is locked it cannot be changed so this “data cleaning” - if you even want to call it that is essential and it’s important it is done correctly. In this case the trial sites did not comllete this process yet. The data has remained blinded and has not been sent to Annovis to analyze yet. Maria is optimistic and very ambitious in her targets especially since she scheduled the data release only a month after trial completion (as a counter example even big pharma typically takes 2-3 months to complete this process. To take advantage of this anouncement as well as speeading false information and doubt to manipulate stockprice is unethical. I stand by my statement and if you are indeed short as I believe or paid to spread misinformation is like I said before unethical.
How can accuse me of false information?
As follows:
Delayed results - fact from press release
New patent application for using drug for mental illness 6 days after delay information released- fact from company press release also
No information regarding open label extension of trial - check their website
Unlike you, I have no financial interest in this company, nor am I being paid. Merely want to see transparency and honest results.
Transparency and honest results by calling it a scam.
Data cleaning is done while blinded. Dozens of testing sites allow for human errors in transcribing data. The cleaning process is done to ensure the data set is accurate. Absolutely nothing is done to pretty up or skew results. It happens in every clinical trial. A delay is just that - a delay. Nothing more, nothing less.
It could end up that it doesn't work. But that won't be because of cleaning
You’ve spewed so much BS on this forum:
“Annovis Bio announced that they are filing for a patent for the use of Buntanetap for mental illness. Meanwhile, the data is still being “cleaned “ from the PD study. I am starting to feel this company is a scam. I doubt the clinical data was positive, hence the “data cleaning.” Now a new patent application for this supposed do it all drug, yet no word on an open label extension for PD.”
Here you are falsely assuming the company has the data despite it being reported that the data is still blinded. The 3rd party company running trial sites has not locked the data yet as stated in numerous press releases. You are asserting that the CEO is lying and state that the company is a scam. This is defamatory.
And yea it is applicable to many diseases. The MOA preventing translation of multiple neurotoxic protiens has a wide range of applications. Do uou realize this is the first drug to significantly reduce the toxic protien TDP-43? Did you know that ALS drug pipeline for example is mostly drugs targeting this biomarker (none have managed to this) and Buntaentap has already been shown to reduce this by 71%?
And saying that most people have had negative experiences - also a lie. Half on this forum have reported positive experiences on the drug & half no change, so to state nobody has is deceptive.
I’m open about who I am and my intentions, you haven’t been and frankly tired of your BS. At least if you are going to criticize the drug be truthful. Misinformation for the purpose of manipulating the stockprice is illegal. And to say the CEO is lying and implying she is breaking the law when she has not only committed her life to fighting this disease but has been 100% invested spending over a million dollars purchasing her own stock and never selling a share even when she could have easily done so when the stock was over $120/share (and gotten very rich) is ridiculous. She’s the most transparent CEO I’ve had the pleasure to invest with and for you to spread BS and lies like you are now is disgusting
All my BS comes from the company’s press releases. Since you appear to be a scientist let me break it down to a simple formula:
NO OPEN LABEL TRIAL FOR PD + DELAYED TRIAL RESULTS + NEW PATENT APPLICATION FOR DIFFERENT ILLNESSES W/O INDICATION OF ANY REAL STUDIES = THE RED FLAG OF SHENANIGANS
For the record I am not implying anyone broke the law, but in my honest opinion the sequence of events causes me to question whether the product achieved its endpoints.
Once again I have NO FINANCIAL INTEREST with these posts. I just dislike PwP (or other illnesses) being used as pawns for financial gain by people as yourself. Unfortunately, a huge portion of the Parkinson’s pipeline is not about seeking a treatment or cure, it is about keeping the money flowing in.
Judging your attempts to discredit my posts and I, you have a lot more to do with this product than a mere investor. Perhaps there is a paycheck on the line.
Cheers my friend
Also, if you have no financial interest, why are you so fixated on stock price?
I posted once about stock as an indicator of product performance. Hardly a fixation.
I suppose it's just a "coincidence" both of your posts coincide with downturns in stock price.
I'm just taking the same liberties that you do. Stock downturns, your posts. Data delays, scams.
I view stock values as a major indicator of business or product performance. When the value was up a couple of weeks ago I was happy thinking there was going to be a new effective treatment for PD.
Also not just the data delay causes me to question product performance. It is the totality of circumstances. Six days after delay announcement a patent filed for product use in mental illness. Where are the studies? Then, of course, no open label trial for PD.
I sure wanted Buntanetap to succeed, but based on the many posts I have read on this site, as well as the company’s action, cause me to question both the company and its product.
You haven't answered question I asked you yet. I've done my DD. Hell even got neurologist friend to read over the material and said it's very promising. Considering some folks got full range motion and smell back
How much of score improvement did these folks have? Did you see or speak to these folks? Was improvement caused by placebo effect? Listen I hope it succeeds, but based on factors I keep mentioning, I have my doubts. If Annovis Bio has so much belief in their product, they should do the right thing and offer it for compassionate use.
Company cannot offer open label extension until they know which one is taking what dose or placebo. Just common sense here. Hence they have to wait till after data cleaning, data lock, data unblinding and finally analyze results and release the top line data.
Danger about posting misleading information here John is, there are a lot of people here who are actually suffering from the disease and it’s grossly unethical and insensitive of you to be doing this for your own personal gain.
There is alot of money involved here and I advise those who are a part of this community to keep that in mind as not everyone here has good intentions or even has Parkinson’s.
You're warning people about those with vested interests and no PD whilst being someone with vested interests and no PD?
JohnP65 nor Mr Colorado could move the share price a dime by ranting on here, for all the puff and hot air about defamation. It does look like Mr C has bet the ranch on this one though 😂
You’d be surprised Winnie. This is a small cap stock with a very low float and low trading volume. There are a number of ways I & others can move the price, in either direction.
I'm sure if you have the money to buy or sell shares you can move the price. But you won't move it with hot air on here. Nor will anyone else. Please piss off and talk investment nonsense on an investor website. This forum is for people with Parkinsons disease
Exactly correct! The intent of my original post was to inform PwP about news regarding Buntanetap. Like many here, my interest here is not money, but rather new and effective treatments. Unfortunately, as I mentioned before, the Parkinson’s pipeline is filled with scams focused on financial gain rather than effective treatments.
Winnie, in the end the stock does matter. It is how these trials are funded so it is directly related to whether or not there will be another clinical trial for patients here. Some have reported good results.
I won’t comment anymore but I could not stand by quietly with so much false and defamatory statements about the CEO & company are being posted here.
DrColorado:
How do you know “some have reported good results?”I thought the study was blinded, and even Annovis Bio knew nothing.
Since you are a wealth of “ethical” information, please tell us what was the catalyst behind the timely filing for a new patent for the product use in mental illness. Surely, the company has study data supporting Buntanetap’s use in mental illness. I would view anything less as “the Captain trying to save a sinking ship.”
MrColorado has decided to retire from a discussion which has more to do with investment issues than PD. He objected to unnecessary hostility towards the CEO of Annovis. And so do I.More to the point I object to this forum, which is for PWP to share experiences being sidetracked into a small cap investors battle ground.
I would ask anyone who doesn't have PD to pursue investment issues on another site.
The thing is we know that Prasinezumab started showing some effect after almost a year and a half. That was an alpha synuclein antibody. This is alpha synuclein inhibitor and the treatment period is just 6 months. They kind of shot themselves in the foot.
There is discourse in the scientific community whether alpha synuclein accumulation is harmful because it is entering neurons and causing damage or if there is an added effect where aggregated alpha synuclein is no longer in its monomer format so it is missing and not doing its tasks. Having an inhibitor covers both of those modes of action.
However them delaying the release of data definitely tells me they are trying to find anything beneficial there to get an approval from FDA.
They should have had a treatment period of at least a year. However maybe there was no improvement in those that took the drug but also maybe there was no degradation.
I guess we will find out in a month or so.
Just relaying what I was told during the trial When I asked why the study was such a short time, the Dr said because there are so many participants, the large number of people means the study can be a shorter time.
That’s what he said.
The trial should have longer. At least 18 months for a phase lll trial.
I suspect part of the reason for the short trial is because the early studies appeared to work well and quickly. I think if was a risk for them to make it six months but if it does show efficacy that quickly it will make it easier to expedite FDA approval which would be great for all of us struggling with this disease, trying to eat right, exercising, taking the latest supplements trying to slow the progression until something comes out that works before it's too late.
Exactly my thoughts. II think if this can actually slow progression on its own it might not seem much but coupled with exercise and supplements the effect might be stronger.
Also this would just be something to buy more time until better things come along and there is some interesting stuff in phase 2 trials and others that are just about to start Phase 1 trials.
Press releases indicate the Company remains "blinded" to the data. They have not seen the data yet from a 3rd party. They did a mixed shelf on Thursday and stated in that press release they are still blinded. So your statement about them seeing the data is BS.
You are right. There is not any data cleaning by ANVS, CRO might clean before giving data and to ANVS. And it's normal and done in every trial.
If you truly believe they have no clue regarding product performance during the trial, I hope you made a huge investment in their stock. How many PwP did it help on this site?
They may not know which patients are in which group but they will have an idea back from the clinics about effectiveness. If nobody is doing very well then you really don't need to worry about which of that group was on the drug and which ones placebo
Exactly
Dude several participants bought stock in anvs. Loads of positive feedback. You must be sweating your short position
Their stock was doing good for a while than started tanking again. Not a golden ticket in my book. Perhaps fool’s gold.
You know next to nothing about investing if you view a run up prior to data as the drug works or a decline in share price, again prior to data as the drug doesn’t work. Stick to what you know, making claims of scam and false accusations of the company lying about being blinded. You’re an insult to this great community
The fact that they feel confident enough to apply for another use variation of the same drug I took as a good sign!
Do we discount the numerous members who have shared their positive experiences from their trials. If there weren’t so many people claiming to have experienced benefits, I would agree with you that the patent PR from a timing standpoint seemed pumpy. But, considering the company claims they are still blinded to the data, this is a bold claim you make.
Exactly how many compared to no effect?
9 positive experience, 2 maybes, 8 no’s
I didn’t find any posts that showed 9 positive results. The most I have seen were 2 positives and the rest had no effect.
docs.google.com/spreadsheet...
Nice work!
Really? I would say that was near conclusive proof of failure. A close look at the "yes" show a huge variation. Take MB Anderson. He was not sure, and then thinks it fixed his constipation
Is that likely to be a primary or secondary endpoint?
Ok - so if it were a secondary endpoint none of the other trial participants mention the benefit. Is that a statistically significant clinical improvement?
There are 9 "Yes" (including Marc) 2 "Maybe" and 9 "No"
Maybe1 - bullard is a "No" - "will we ever even know if we received placebo or not? Whatever I received did nothing for me"
Maybe2 is a "yes"
That's exactly 50:50
Now - say measured outcome is "statistically significant updrs part 3 score improvement"
Marc becomes a "no", tacato is unclear but we'll call it a "yes", Next stage is a "No" partly because of all the muddle about other changes of regimin but conclusively because of "I don't know if I had the placebo or not.". That's 9+1+1=11 "No's" so far,
Ctime is a "No", zogi a "No" (movement got worse), Xnay is ambiguous but we'll leave it a "Yes", ParkieDude is a "No" (smell, concentration etc is not updrs 3), emstadler is just too bloody long so we'll call it a "Yes", Bratveria "Yes"
I make that 14 "No" and 6 "Yes".
I know some will be on placebo but look at the placebo improvements in the phase 1 trial. Also, I know it is hoping to be a disease modifier, but in that case, without symptomatic improvements , 6 months was a joke doomed to failure. The premis must be they are looking for approval on the grounds of symptomatic improvement, the results they flaunted in the previous trial, and that's why 6 months was sufficient
And, on these results, it's nowhere near
(I find it slightly amusing that acording to our adamant forum experts, apparantly Annovis are completely blind and have no idea about the outcome, but a couple of forum experts here , from a far more limited data set, know for certain it's a success)
Count it anyway you wish but please don’t discount real PwP anecdotes. You are talking about trial endpoints while people are reporting symptom relief. You understand that constipation is a very common symptom of Parkinson’s, no? Sense of smell loss is often one of the first symptoms.. Your motives are very questionable. This whole thread is disgusting. You “people” bashing a CEO who has spent her life dedicated to the neurodegen field and has spent millions of her own money and never sold a share because she believes in the science… this entire thread is gross, take your investing advice to stocktwits
I'm not bashing anyone. I just have doubts about the likely success of this trial and medication. Nor am I offering investing advice As a PWP who has lost his sense of smell, and suffered severe constipation, I don't need you to remind me about those symptoms. I am interested in a drug that will help me. But the spreadsheet offered in support of this molecules success is a string vest.
The data cleansing won't take forever - so we'll know soon enough. In the meantime, nothing said here is going to change that outcome, so have a nice relaxing bath, a glass of red wine, and chill a bit.
Annovis opted for the short duration significant symptom improvement route - not the disease modification route - which would have required at least 2 years of trial duration - and the anecdotal reports of phase 3 are nowhere near the phase 2 outcomes that influenced this choice
"In a phase 2 trial (NCT04524351), individuals with PD (n=54) who were treated with buntanetap vs placebo, at day 25, had a dose-dependent mean 2.43-point (13.4%) improvement on the Unified Parkinson Disease Rating Scale (UPDRS) compared with baseline (P<.01). Statistically significant improvements on the Wechsler Assessment of Intelligence Scale (WAIS)-coding subtest with buntanetap vs placebo were also seen. "
As for TDP43 - the discovery of its efficacy was only for the 10 patients on the 80mg dose which was not used in the phase 3 trial , and we don't need to go down the biphasic route again.
We'll know soon enough
Actually, it occurs to me that it is a bit rich for some arsey little Herbert who joined last year, has no bio information, no posts, and just 5 replies all defensive nonsense apparently primarily about Annovis stock values to start making offensive threats to a genuine pwp who has been around the block on this forum. This is a forum for PWP and their carers, not biotech investor researchers.Accordingly I propose making you my counsellor on sexual matters. Or "when I want your f***ing advice I'll ask for it"
this entire thread is gross
Yet it is literally the only thread to which you've contributed. Maybe the lot of you that have a far greater interest in the fortunes of this company and its CEO than you do PD should take a walk and talk about it elsewhere. As for 'real PWP anecdotes', you can tell a group of PWP that putting pineapples in their backsides is likely to improve their condition and a good chunk will come back telling you it did do, such is the absolute desperation that the community has for a solution (or even part of one) now and not in 25 years (or at the rate we are going, 50). Many of us have learnt that anecdotes aren't worth much.
When I said "Good work!" I was referring to BMWbot 's thoroughness in compiling this data. At this time I'm agnostic as to efficacy.
You said "Next stage is a "No" partly because of all the muddle about other changes of regimin but conclusively because of "I don't know if I had the placebo or not.". "
Interesting logic. Because I had regimen changes AFTER the end of the study, and because I admitted that I was still blinded to whether or not I had received the actual drug versus a placebo, then I am a "No".
OK. Thank you for clarifying. I take it you felt you definitely achieved UPDRS part 2 and 3 score improvements that were statistically significant, but you acknowledge that could have been a placebo effect That would make it 13 v 7.
It is of course just a review of a selective small sample of participants - but I think much less unequivocally positive than we were hoping for given the phase 2 results. Annovis are currently forecasting results in the first quarter of 2024, so we shouldn't have too long to wait.
Maybe the silent majority have all benefitted enormously.
Incidentally - don't dismiss placebo affects as "just imagining it". On the Biogen SPARK trial I was fairly sure I was on the drug (and I was) and one of the effects was that after treatment (4 weekly) for a couple of weeks the puffy swelling around my injured right eye reduced - so my usually nearly shut eye was wide open and normal. Biogen abandoned the trial due to inadequate evidence of clinical improvement=
"That would make it 13 v 7."
I know that this is overly simplistic, but it seems to me like maybe the 20mg dose worked, and the 10mg dose (and the placebo) didn't work.
Maybe. But probably not. Maybe it works for some types of PD and not others. But again, probably not. Like all the pwp on here I would love to wake up and hear it works. I'd be front of the queue for the doctors to prescribe it. It's hard to have very high expectations of that outcome based on the balance of comments I've read over the last year or so...
I took part in the trial and saw no discernable changes. Maybe I was given the placebo. However, whenever someone posted or replied that they also participated, I sent them a private message to compare our experiences. The overwhelming majority experienced no benefit. I did get messages from investors hoping to have hit the jackpot. In my opinion, Annovis Bio is better at attracting investors than in treating Parkinson's Disease.
Hi Jim, Thanks for your response. I see on your profile that you wrote the following "I feel totally normal about 99 % of the time. I am very happy that the progression is not advancing as quickly as I originally feared. " - What were you expecting from the trial if you feel fine 99% of the time?
I feel normal because of carbidopa levodopa. Part of the trial required going without carbidopa levodopa for at least 12 hours before each clinical visit. It was very evident that buntanetap (or the placebo) did nothing. I did not improve in the objective, timed tests. No one feels worse about that than I do.
so are which one is it? Your previous statement that you seem to have positive effect? Or your current negative sentiment?
Nice try, Perry Mason. I function well because of carbidopa levodopa. Buntanetap did nothing for me. I wish that was not the case, but both statements are true. I feel normal because of carbidopa levodopa. When that was withheld as part of the buntanetap trial, I didn't function well.
Thanks for the response Jim and that clears up my question. Take care and I am glad that carbidopa and Lebodopa are helping.
Google parkiedude reddit buntanetap. Very positive feedback. Equates the drug as winning a golden ticket.
Google parkiedude reddit buntanetap. Very positive feedback. Equates the drug as winning a golden ticket.
I am PWP I throughly hope this drug will work. One thing worry me is if you follow twitter on Annovis, you can see the following lots of non-medical share market/ investment posts …
My posts about the improvement I saw can be found elsewhere on this site but one piece of “objective” data I have is this: Scores on the UPRDS - at diagnosis in 2017: 8; pretrial in January 2023: 18; last trial appointment in July 2023: “under 10”; 6 months post-trial in January 2024: 6. Better than I was at diagnosis 6.5 years ago. Do I know if I was the drug yet? No. Because it is still blinded to everyone except the third party stats people. Am I hopeful? Absolutely. Really hoping the data shows there are others who showed improvement/slower progression and I can go back on it. But for now, I still have my arm swing back after losing it in 2015.
Is your arm swing something you could have reported as an improvement in MS-UPDRS Part 2? I believe that’s their primary endpoint now.
Arm swing would not affect a UPDRS 2 score. It might influence 3.10. You shouldn't score 0 on that test with impaired armswing. The trial has UPDRS 2&3 as its primary endpoint.
photo
screenshot of the clinical trials.gov website last updated 23 december 2023. If Annovis want to change the goalposts for a drug authorisation they need to do more than post slides on their investor presentations.
That slide gives a reference of NCT04524351. That's the previous study
classic.clinicaltrials.gov/...
Maybe they should have looked at their current study for the trial they are talking about before they prepared their investor slide
classic.clinicaltrials.gov/...
The scores I was given were my total scores and not separated by parts. After looking at the part two questions, I know there were some things that definitely improved. Things like I was able to cut my own food for the first time in several years, I could more easily get up and down out of a low car, or a chair, I could button my jeans more easily, my handwriting improved.
I look forward to learning if I was on the placebo or not. I usually get side effects from most drugs, and I got none from this with the possible exception of resuming monthly cycles, for the duration of the trial. And I have not had one since the trial ended. 🤷♀️. Fingers crossed.
My hope is that Buntanetap will be part of a multi drug cocktails for a variety neurological conditions, some acute and some chronic.
I have thought about Buntanetap a lot. Before, in the trial and after. Read most of the papers on it under this name and the previous, Posiphen.
I do not think there is going to be a single drug that magically cures PD. PD is a spectrum of diseases with multiple causes and symptomatic manifestations. My hope is that in 5-10 years we have SEVERAL drugs that work to reduce disease progression for those who are at substantial risk, have been diagnosed and those that have been dealing with PD for years.
I also hope there is a special place in hell for people who use their good fortune to short companies who are doing their best to move humanity forward. The system we have is certainly imperfect.
Those who chose to make life worse for their own profit instead of using their health, wealth and talents to reduce human misery are explicitly evil.
Anyone notice how Annovis Bio handled the failed Buntanetap trial in AD. I wonder how much longer for the PD study to be released.