This just in my inbox! Good news for Annovis as it will give them time on Parkinsons!
"Dear Friends,
Annovis Bio has announced the results of our Phase II/III Study of buntanetap in patients with mild to moderate Alzheimer's disease. Please see the attached press release for details.
We would like to thank our participants and their caregivers for being a part of this important study.
Annovis Bio continues to prepare the Parkinson’s study data for analysis.
Annovis Team
Maria Maccecchini, PhD
President & CEO"
Written by
Ctime
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Seems there was 2 primary endpoints n it failed at one. There was also 2 cohorts n they only reported on one. The assumption is that the other one failed. Very strange behaviour for the company. Its very positive that there was some positive results and is certainly not bad news for the parkinson trial. But the way they're delaying the reporting of that data is very bearish so I guess most investors are thinking it'll fail. Company is run very strangly overall.
I think he is referring to the fact that there were 325 participants but they only used a post hoc subgroup of 90 participants who were early stage and had biochemical markers of Alzheimer's. Post hoc subgroup analysis is frowned upon because it is way too easy to find some subgroup who did well for random reasons. In this case I think their subgroup makes sense, but that remains to be proven in a phase 3 trial.
In addition there's the overhang of needing financing and phase 3 Parkinson's results which are way late.
If they were perceived to be mining the AD data for positive nuggets and we still waiting for PD results, things are not looking too great. I think it would be wise to temper any optimism here. At least financial optimism which is what Annovis needed, independent of the science, unfortunately.
The reason why the stock is tanking as it didn't meet one of its endpoints. I think the big one was the "ADCS-CGIC".
"But another endpoint in the study, examining the drug's impact based on an assessment called Clinician's Global Impression of Change, was not met, with no statistically significant difference observed across all dosing groups of patients compared with a placebo group."
"The "ADCS-CGIC focuses on clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of a trial."
So what I think is happening is... Even though there was improvement in the cognitive testing scores in comparison to placebo, the clinicians didn't feel there was improvement overall in comparison to the placebo.
Like Parkinson's trials, it seems like there is an urgent need to focus on better screening biomarkers for disease variants but also to use OBJECTIVE measurement devices (which do exist and have been clinically validated) . Without quantitative, objective data trials will continue to be ambiguous and require very long study periods to demonstrate significant efficacy.
I think the PD trail will show similar ambiguous results and unfortunately Annovis is likely done. WHY we are still basing the outcomes of these trials on infrequent UPDRS subjective assessments when cheap accurate measurement tools are available is beyond my comprehension.
Bio99 shared an interesting tweet on the plunge in Annovis Bio share price
Today’s plunge in the $ANVS stock price was a knee-jerk reaction to the preliminary Phase II/III trial results for Buntanetap in treating Alzheimer's. Yes, there's been some chatter about the small sample size and the nature of the analysis, but let's zoom out and look at the bigger picture. The results actually showed a notable improvement in ADAS-Cog 11 scores, with a 3.3 point improvement for the treated groups compared to just 0.3 for the placebo. That's a significant difference and sets the stage for a more targeted and potentially game-changing Phase III trial. Compare it to approved Leqembi which resulted in a slightly less bad ADAS-Cog 11 result after 18 months of treatment, ignoring the ARIA of course.
The market completely missed the point here. The drop from $18 to $5, then a slight recovery to $7, seems more like panic selling influenced by complex positive feedback loop dynamics in the options market rather than a rational response to the drug's prospects. Annovis is gearing up for a Phase III trial that will be smartly designed to leverage what they've learned so far and the FDA will love it because it will have biomarkers and a lot of patients and be long enough to show massive differences magnified from these ones. Watch out if they do an interim analysis at 9 months and the FDA jumps to accelerated approval. They’re going to be focusing on patients more likely to respond to the treatment, which could really refine the efficacy of Buntanetap. Remember early AD is a vague and grey area. Patients will be molecularly defined now and it will make all the difference in the world.
Let's not forget the upcoming Phase III results for Parkinson's Disease, expected in just a few weeks. If those results are strong, they could completely change the narrative around Annovis's future. Plus, with an Equity Line of Credit in place, Annovis isn't facing immediate financial pressures—they won't need to dilute shares just to raise funds.
In the end, biotech investing is always a bit of a roller coaster. Early reactions to complex data can often miss the mark. Annovis seems to be on a solid path with Buntanetap, targeting not just symptoms but potentially altering the course of neurodegenerative diseases. That’s a big deal. If you're thinking long-term, this dip was a buying opportunity before the company possibly reshapes treatment for Alzheimer's and Parkinson's. Keep an eye on this one—today’s market reactions might soon be seen as an overreaction, especially if the upcoming trial data hits the mark. I will be continuing to slowly accumulate.
Now that the market maker dehedging their call writing is over and knee-jerk investor selling is over and short sellers realize they are now very overexposed and the future does not look good for them to hold on to their position, watch out for a recovery as brutal and surprising as the decline was. Markets love catching everyone offsides and destroying both large long positions and short positions. Just see what happened last week to the big tech companies’ stock, jumping or falling 10% all of them. Remember also that Annovis has always been priced for failure. A $100 million stock is not priced for approval. That means that yesterday’s news actually totally derisked its future even more because the likelihood of successful PD and AD trial results in the future just jumped. Today’s news if you think deeper about it bodes very well. Molecularly confirmed patients’ thinking IS improving by the most objective measure available and the improvement is miles ahead of everyone else’s drug. Best of luck!
I think if you wake up and smell the coffee this is a bust. Much as I would love it to succeed, I think it exceptionally unlikely that I will be queuing at the pharmacy for this one. Not because it won't be authorised but because it only hoovers up irrelevant protein plaques and doesn't provide a worthwhile therapeutic benefit. Both AD and PD trials were poorly planned and poorly executed, and the extended delay releasing the PD results screams out.The stock price is hanging on by its bloodied finger nails in the hope the PD results will be good. And in anticipation of those good results I have ordered a celebration feast of wing of pork.
It's a bugger. I could really do with something spectacular, but it's not going to be this one.
if you read past the press release's positive spin, the company eventually admitted what really matters—the main goal of the study was not met. The trial was actually assessing a statistically significant outcome in ADCS-CGIC or ADCS-ADL. ADCS-ADL is yet another Alzheimer’s scale that measures activities of daily living in patients with the neurodegenerative disorder.
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ANNOVIS BIO ANNOUNCES POSITIVE FDA NOTICE FOR BUNTANETAP PHASE 3 CLINICAL TRIAL IN PARKINSON'S DISEASE
“Annovis Bio delivers candor on its Parkinson’s study, even if it doesn’t inspire much confidence”
Annovis Bio's Phase 3 trial of Buntanetap/Posiphen: Trial record has been updated (contacts and locations)
