Replies to post #462198 on Anavex Life Sciences Corp (AVXL)

[12x]

Any thoughts on why CGI-I wasn’t listed in trial design but was presented here as an exploratory endpoint?
It’s worthy noting there is no company PR so far (maybe on Monday) if it’s considered material event of announcing full dataset or change of TLR.
Any example of a completed clinical trial with only one co-primary endpoint statically significant (but not the other) able to submit a NDA (or adjust the SAP) based on FDA guidelines change?

[Hosai]

If you are saying Annovis PR is incorrect and they actually have 7 minutes to present instead of 45 that would be pretty incompetent on their part, unless perhaps the event schedule has not been properly updated.

"Dr. Cheng Fang, Senior VP of Research & Development at Annovis Bio, along with Kathleen A. Welsh-Bohmer, Ph.D., Professor in Psychiatry and Neurology at Duke University, and Maria L. Maccecchini, Ph.D., Founder, President, CEO of Annovis Bio Inc., will deliver a 45-minute oral presentation in a Developing Topics session, highlighting the significant findings from the company’s recent studies of Buntanetap in patients with mild AD. The presentation will also provide an in-depth look at the drug's efficacy and safety in both APOE4 carriers and non-carriers, underscoring its potential as a breakthrough treatment for AD.

“We look forward to sharing the details of our Phase 2/3 results with the scientific community at this prominent conference,” said Dr. Cheng Fang, Senior VP of Research & Development at Annovis Bio. “We are also grateful for the 45-minute format, which allows us to present our data comprehensively.”

[sab63090]

Doc328
I just worked my way up and read your post....thanks for the clarification.....I still like Maria's style in letting people know how long she will be taking questions, Missling should have "done the same"....

[WolfofMia]

Ofcourse you are interested in the one endpoint that:

a) We did the worst on.

b) The FDA just dropped as a required endpoint!!!

Lmao!!

[12x]

It looks like the AD p2b/3 full data results will be released in the following 4 upcoming events. The way the presentations/releases are sequenced makes one wonder whether the trial was much more successful (outside the co-primary ADCS-ADL) than people realized. It also seems Marwan is taking over the medical conference presentation duty from MS.

1. Blarcamesine in Early Alzheimer Disease Phase 2b/3 Randomized Clinical Trial (AAIC 2024 7/28) - "In this phase 2b/3 randomized clinical trial, we found that among participants with early AD, blarcamesine significantly slowed clinical progression on prespecified primary outcome global and cognitive measures at 48 weeks in the ITT population. These results suggest that blarcamesine may be an effective, safe, and novel scalable oral treatment for early AD."
To announce final p2b/3 results: first time disclose ADCS-ADL results (not stat sig) but Cog13, SB, and CGI-I stat sig

2. Pre-specified SIGMAR1 Gene Variant Analysis in Phase IIb/III Trial Supports Precision Medicine Mechanism of Action (MoA) with Improved Treatment Effect of Blarcamesine in Early Alzheimer Disease (CTAD 2024)
Pre-specified SIGMAR1Gene Variant subgroup must be significant. Otherwise, why present it in CTAD?

3. Analysis of RNA sequencing (RNA-seg) of the Phase 2b/3 data expected by mid-2024 (Anavex June Presentation)
Must be good results? Otherwise, why call it out?

4. Data from the blacamesine Phase 2b/3 ANAVEX2-73-AD-004 trial to be published in an upcoming peer-reviewed journal (Anavex June Presentation)
The company has disclosed most of the full data already at this point. The dose-response subgroup might be the only thing new if not disclosed in AAIC-2024 and biomarkers.