Annovis Announces Unblinding of the Buntanetap Phase III Data in Parkinson’s Disease

[Farooqji]

"When we reached the point of unblinding the data for the PD Phase III study, we discovered an unexpected issue: too many plasma samples showed no presence of buntanetap. We were expecting 33% blank samples from the placebo group, but we saw over 50% blank samples. We were afraid that we had mixed up bottles and that patients weren’t given what they were supposed to. If that had happened, the study would have been worthless. We promptly started searching for a possible explanation at every step of the way. We checked the content of the bottles – correct. We checked the distribution of the bottles – correct. We checked the labeling of the plasma samples – correct. We checked the distribution of the plasma samples – correct. So, we were left with the pharmacokinetic (PK) measurements. PK is measured by LC-MS/MS with a very expensive set of equipment under GLP, GCP, GMP, and is regulated by very strict FDA rules. It turns out that the group, which was evaluating the PK, modified the method, unfortunately affecting the measurements. We repeated the PK of the same samples and obtained an expected 33% of blank samples accounting for placebo.

globenewswire.com/news-rele...

[Parkinsonjisung]

Exciting news. The AD results weren't exactly inspiring but hopefully the parkinson ones are a winner. Really good news on the what happened to the samples. Roll on June.

[ChucklesUSA in reply to Parkinsonjisung]

I was inspired by the AD results, despite the need to evolve the trial design. Simply put, when Annovis became aware of issues from other AD studies with sites recruiting non-AD patients, they added AD biomarker measurements by collaborating with C2N Diagnostics. Only 202 of the 325 participants who completed the Phase II/III study were confirmed to have AD based on an assay developed at Washington University in St. Louis by Dr. Randall Batemen and others. Annovis then stratified the population with AD between mild and moderate AD. While these actions were not pre-specified, they revealed statistically significant improvements measured using ADAS-Cog11 in the mild AD (MMSE 21-24, pTau217/tTau≥4.2%) population versus both baseline and placebo following three months of treatment (N=90).

As you may know, existing approved AD Disease Modifying Therapies do not improve cognition -- they merely slow the rate of decline. Also, the reported cognitive improvements in mild AD participants appear to be greater than those previously reported for approved Symptom Modifying Therapies in AD; however, the populations and measures may not align precisely.

The moderate AD population in the Annovis Phase II/III AD study was later reported to show a smaller improvement versus baseline; however, placebo effects in the moderate AD population obscured the benefit versus participants who received the placebo for three months.

Happy trails,

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[MarionP in reply to ChucklesUSA]

Very nice thank you much

[Pixelpixie]

yeah well, not really. I called them to get my assignment and they said July. First test results in 2 weeks, then centers get notified in another 2 weeks. July if we’re lucky

[Shorebird]

Thank you! 🤞🙏🏼

[MarionP]

Good news and bad news. The good news was that bunentap so far is preserved for at least miles, and perhaps a bit moderate, affected AD. The bad news is that the producers of the testing equipment frankly fu**ed up and who knows how many other research projects were affected by their error and not caught.

[MarionP]

Thanks very much for catching this.

[LeharLover62]

More waiting…..seems like that’s all we do. Let’s hope this turns out well.