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https://news.sanfordhealth.org/research/kevin-francis-batten-disease/
This Stanford lab is pre-clinical testing multiple Anavex compounds as a treatment for Batten disease.
From the article:
Dr. Walter Kauffman collaborated on this newly published Rett Syndrome biomarker research report. Important research / interesting read.
https://www.frontiersin.org/articles/10.3389/fnint.2020.00007/full?fbclid=IwAR2or35lRaljEiQrypRk05dlwt1w8_n4d4HOfVkL_-u7Z_0bQXlzibhzcDs
Abstract:
New, from Robert P. Lisak's team at Wayne State: https://www.sciencedirect.com/science/article/abs/pii/S0165572819305831?fbclid=IwAR1OY6pp_mY-DuBDPSBBepLujSKm0dSJ-iGu7YfgWVbG5moO0gwv2EDlzVM#
Nice catch Kevli33. There's also this position currently listed:
https://www.indeed.com/viewjob?cmp=Anavex-Life-Sciences&t=Clinical%20Supply%20Director%20Senior%20Director%20Yrs%20Exp%20Req&jk=97d29bca8ae5ac72&sjdu=QwrRXKrqZ3CNX5W-O9jEvcj5ae13bOP2tAebFrKJVCbCdpUV2M6U8jR2_E7OfIKDasNSn0vHPCIbt8o9KGNwRK5kDYhLXCIV-yLYlrb3UZJ_Zo4QkJf3Yh2IWmZulbmD&tk=1e137l6ts0n3o000&adid=337099817&pub=4a1b367933fd867b19b072952f68dceb&vjs=3&fbclid=IwAR39D_RVQ6RWjWfhAqII5CESS3_ddCx7AjYfmnLH2lFl5EiSZb9uXj0WBPI
Both the Senior Clinical Trial Manager position you posted, and this Clinical Supply Director/Sr. Director position are different titles than the previous handful of postings from last summer/fall which included Clinical Data Manager, Manager of Clinical Operations, and Medical Writer.
2 research notes issued by Dawson James this past week:
2/4 (after the Fast Track news): https://files.constantcontact.com/fdcb5758701/2c3ad5bb-f8ff-4155-beb0-46082366c9aa.pdf?fbclid=IwAR0RlMP0HFNq9nkfmLFH5dzQ2AhmuhGqJ9HLJENF2dSTovBpASF2byL1268
2/7 (after yesterday's Q1 call): https://files.constantcontact.com/fdcb5758701/a357998e-f774-4dfe-b481-1355e5723c45.pdf?fbclid=IwAR0ZOJMT_AaHKpMtsJsHd6c7jOVxIdj2X9GTK5d12qQMTAEB6i1wn07RpRI
ANAVEX1-41 resurfacing? On May 20, Dr. Missling will be at the 3rd Annual Neuropsychiatric Drug Development Summit. Per the draft agenda, he will present:
It was the "Alzheimer’s: Beyond the Rise and Fall of Amyloid" panel at the 31st Annual ROTH Conference on March 18th.
https://www.globenewswire.com/news-release/2019/03/13/1752370/0/en/Anavex-Life-Sciences-to-Present-at-the-31st-Annual-ROTH-Conference-2019.html
There was video that has since expired:
http://wsw.com/webcast/roth33/register.aspx?conf=roth33&page=panel22&url=http://wsw.com/webcast/roth33/panel22/index.aspx?lobby=true&day=2&fbclid=IwAR3aVAJ3vG-dCt_usQzK41Kh6vDRPeGOJGY8nwTjbHvVYBfcsaCC1Vnx0fw
Update to the Microbiome Connect: Human USA conference on June 3rd. The program has been posted with the title and description of Dr. Missling's 3pm session:
Thanks for the relevant patent link.
For those interested in the science, here is an in-depth research paper in the Journal of the American Heart Association that was published the same month of this patent filing: Cardiac Dysfunction in the Sigma 1 Receptor Knockout Mouse Associated With Impaired Mitochondrial Dynamics and Bioenergetics
Nice addition and reminder — thanks!
It will be interesting to keep an eye on any further findings around the potential cardioprotective effects of 2-73.
I'm not sure if this was discussed here already, but Anavex CMO, Walter E Kaufmann, published a Commentary article last week, Long QT interval in Rett syndrome: expanding the knowledge of a poorly understood phenomenon, commenting on an article published late last year about a study on the subject. In his commentary, Dr. Kaufmann discusses the findings of that study and prior information about prolonged QTc in RTT. He discusses and raises questions about the stability of QTc measures, the potential for drug interactions to be a contributing factor (particularly SSRIs) to long QTc, the extent of the link to RTT clinical features other than breathing abnormalities, the need for biomarkers to help determine the risks, and ultimately the risk of sudden death due to long QTc.
To me, this commentary is particularly interesting in light of the fact that back in 2017, in a PK/PD presentation at CTAD, Anavex made particular mention that 2-73 administration had been shown to not prolong QTc intervals and in fact, after administration it shortened QTc by 10ms while it's metabolite ANAVEX19-144 was found to be anti-arrhythmic.
Seems like for this aspect, 2-73 could be a favorable treatment option. Also seems to me that the team is covering all angles of the science here.
Relevant links:
Dr. Kaufmann's paywalled commentary: https://onlinelibrary.wiley.com/doi/full/10.1111/dmcn.14481
Original article: https://onlinelibrary.wiley.com/doi/abs/10.1111/dmcn.14419
Anavex PR from 2017 (last bullet): https://www.anavex.com/new-clinical-data-alzheimers-disease/
Anavex Presentation with QTc findings (pg. 20): https://www.anavex.com/wp-content/uploads/2018/05/Anavex-ANAVEX2-73-CTAD-Phase-2a-November-2017.pdf
https://www.australianageingagenda.com.au/2020/01/31/early-findings-of-alzheimers-drug-trial-show-promise/
Alzheimer’s drug trial shows promise
By Sandy Cheu on January 31, 2020 in Industry, Research & Clinical
Participants in an international trial investigating a drug to slow down cognitive decline in people with Alzheimer’s disease have started to show significant improvements, the principal investigator tells Australian Ageing Agenda.
The trial, which is in its third phase, aims to demonstrate that the drug Anavex 2-73 benefits people with Alzheimer’s disease (read our story here).
Participants are randomly assigned either the drug or a placebo to assess effectiveness.
While the findings are only anecdotal at this stage, improvements have been noticed among individuals involved, said principal investigator Associate Professor Stephen Macfarlane.
“We’ve certainly seen individual patients, who both seem to be getting side effects from the drugs and who have shown significant improvements,” Professor Macfarlane told AAA.
“The findings we’ve got can only be anecdotal because it’s a double-blind trial, which means at the moment, we don’t know who’s taking the actual drug and who’s taking the placebo,” said Professor Macfarlane, head of clinical services at HammondCare.
Participants getting side effects, such as dizziness, suggest improvements from the drug, he said.
“The fact that they’re getting side effects and they were expected side effects based on what we know about the drug, does suggest that the people who are showing the improvements are on the active drug,” Professor Macfarlane said.
“For individual patients who have received benefits, the impact for them has been potentially life changing, such as resuming activities they previously had given away, more interest in life, more engagement and better able to converse,” he said.
For example, trial particpant Rosie Craven had lost confidence and enjoyment in many areas of life before she joined phase three of the study.
“Rosie had enjoyed watching movies and reading but as Alzheimer’s advanced, she gave up reading and found it hard to engage with movies, and often falling asleep. Now after being on the trial, Rosie is reading again and loves watching movies and discussing them afterwards.
“She was losing the capacity to write, had been anxious about leaving home for a walk, and stopped using her phone to communicate with friends and family. Now she is once again confidently going for walks, using her phone and writing greetings on cards,” she said.
Trial still recruiting
The trial, which has been running for a year, is operating across 16 sites across Perth, Adelaide, Brisbane, Melbourne and Sydney, Professor Macfarlane said.
The trial is expected to open new sites in Europe and North America in the coming months, he said.
The trial has recruited around 250 of its 450 target since it commenced, Professor Macfarlane said.
“It might not sound dramatic. Most sites for most Alzheimer’s studies will be lucky to recruit eight patients per site, so across 16 sites, to have 250 in a year is really quite remarkable,” Professor Macfarlane said.
The trial is still seeking to recruit about 225 people by the end of the year ahead of its scheduled completion in 2021, he said.
People living with very early and early stages of Alzheimer’s disease in Sydney and Melbourne and are up to the age of 85 interested in participating in the study can email alzheimerstrials@hammond.com.au
Find out more about the trial and register interest at other trial sites here.
https://www.agedcareinsite.com.au/2020/01/hammondcare-alzheimers-drug-trial-shows-promising-results/?fbclid=IwAR22J52hyD7xy81vllZWIcey78pkbXRzbKjk-7rS6WC2IeJi9FolMo70h1s
HammondCare Alzheimer’s drug trial shows promising results
By: Dallas Bastian in News, Top Stories January 30, 2020
“I’m back to who I am.”
That’s what Rosie Craven had to say of her involvement in HammondCare’s trial of a drug for people living with Alzheimer’s.
Craven has said she’s “back to her happy, easy going self” after joining the trial of Anavex 2-73 in Melbourne.
Principal investigator Professor Stephen Macfarlane, head of HammondCare clinical services, said that before coming on the Phase III trial of the drug, Craven had stopping engaging in activities she previously enjoyed.
“Rosie had enjoyed watching movies and reading but as Alzheimer’s advanced she gave up reading and found it hard to engage with movies, often falling asleep,” Macfarlane said. “Now after being on the trial, Rosie is reading again and loves watching movies and discussing them afterwards.”
The trial also helped Craven more confidently take walks, use her phone and write greetings on cards.
Fellow trial participant Sandra Rozanic also reported finding it easier to engage in hobbies. “I’m feeling a lot better, God yes,” said Sandra.
HammondCare said an earlier Phase II trial saw most participants experience no decline in their cognitive capacity and others improve their mini mental state exam.
So what does Anavex 2-73 do?
Macfarlane said: “We’re still not sure what causes Alzheimer’s disease, but the prevailing theory is the brain is damaged by a build-up of toxic proteins. There have been many failed trials attempting to remove or prevent these proteins.
“The theory behind Anavex 2-73 is that it targets a receptor that, when activated, leads to the removal of these abnormal proteins from brain cells.”
HammondCare has now begun recruiting people aged between 60 and 85 with early stage Alzheimer’s in Sydney.
People in NSW and Victoria interested in learning more can contact the team via email at alzheimerstrials@hammond.com.au or phone (02) 8437 7355.
A drug which appears to slow Alzheimer's is being offered to more Victorians as part of a clinical trial. @EmilyRice28 #9News pic.twitter.com/IqKUXKzlhA
— 9News Melbourne (@9NewsMelb) January 28, 2020
This page on the EMA website detailing the 2-73 orphan drug designation in Rett Syndrome approved back in August was published last week.
Back in November and in December, Anavex 2-73 was on the agenda of the EMA Paediatric Committee (PDCO) for “Day 30” and “Day 60 Discussions” respectively.
I was curious as to why they would be having these discussions about the Orphan status of 2-73 for Rett when that was applied for in May, had the favorable opinion in July (PR’d), and was granted in August. So looking a little further, I came across an "Activities After Orphan Designation page" where it mentions "Sponsors of medicines with orphan designation should also remember to apply for a paediatric investigation plan (PIP), deferral or waiver at the appropriate time, as specified in the Paediatric regulation".
Some complete speculation would be that what was discussed at those meetings was Anavex’s submission of a paediatric investigation plan (PIP) in order to prepare to eventually launch sites for the EXCELLENCE trial in the EU under the umbrella of their EU Orphan Designation. Obviously filling in many things here, but it seems like a plausible reason for 2-73 to be a discussed agenda item over the past couple months. Or maybe they were just on the agenda in preparation for the new web page at the top of the post — but that doesn't seem quite right. Anyhow, the January PDCO meeting will take place 1/28-1/31, so we’ll see if there is any further information then.
Edit: All links embedded within the text of the post added below for those on mobile.
https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3192195
https://www.ema.europa.eu/en/documents/agenda/agenda-pdco-agenda-12-15-november-2019-meeting_en.pdf?fbclid=IwAR0ilXMPrynD3TiLqaHWaDxEhxwRHzNxQ2oKbhB50FVO2d6kslTKJyGP4m0
https://www.ema.europa.eu/en/documents/agenda/agenda-pdco-agenda-9-11-december-2019-meeting_en.pdf?fbclid=IwAR3QmAw3gkd3Z9Q0FdKATol_4VyDediEeZts4pNz0Odk5iFe-Vdbrw4ISzs
https://www.ema.europa.eu/en/human-regulatory/research-development/orphan-designation/activities-after-orphan-designation?fbclid=IwAR0cc8wW01wvXUho1v_3joYupM3At0NgBjfiYdDRO9iJGOmGxuLqhnduS60
https://www.ema.europa.eu/en/documents/other/pdco-meeting-dates-2019-2020-2021_en.pdf
Dr. Kevin Francis of the University of South Dakota Department of Pediatrics submitted a funding application to the Batten Disease Support and Research Association to investigate Anavex 2-73 in Batten Disease; Defining the potential of ANAVEX®2-73- induced inhibition of astrocytosis for Batten disease patient therapy. It is noted that the submission is “to be reformatted for other funding mechanisms”, so the funding may not have been secured. (Pg. 95 of the PDF here: https://www.usd.edu/-/media/files/medicine/pediatrics/pediatrics-annual-report.ashx?la=en)
If you look through the rest of the document, you will see numerous funded programs being conducted by the school concerning Batten Disease, including a few research studies that are screening multiple therapies that may very well include, or have already included, 2-73 in their research. It's interesting to note that they also have a large focus on gut microbiota research within the disease.
Makes one wonder how many other academic/non-profit programs are currently out there with scientists studying, or looking to study, Anavex molecules in various other conditions?
About Batten Disease: https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Batten-Disease-Fact-Sheet
About, Dr. Francis’s lab: https://research.sanfordhealth.org/researchers-and-labs/francis-lab
May 20-21, Dr. Missling will deliver a presentation and participate in a panel discussion at the Protein Misfolding Drug Discovery conference in Boston, MA. https://protein-misfolding.com/
May 20 presentation: Cross-Learnings from Mechanisms of Action Underlying Protein Conformational Disorders, 2:30pm
• How to evaluate the safety and tolerability of novel protein misfolding therapeutics as assessed through clinical development
• How can the commonalities in underlying molecular pathology be used to inform the development of new treatment options for protein-misfolding diseases?
• How can you leverage a clinical developmental strategy to address a range of diseases caused by protein misfolding for which no approved disease-modifying treatments currently exist?
May 21 panel discussion: Conducting a Strategic Analysis of Protein Misfolding Therapeutics, 2pm
• What key learnings can be applied from clinical successful companies in this space?
• What change do you want to see in this space from both large pharma and biotech companies to accelerate robust candidates into the clinic?
• Where are the key opportunities for money flow, partnerships and collaborations to accelerate scientific progress?
• What is the market opportunity and unmet need that makes protein misfolding therapeutics an attractive but high hanging fruit in terms of therapeutic potential?
Program quote from Missling:
“Excited to share insights into advancement of clinical findings relevant to the scientific community and the patient population affected by the respective diseases”
February 11 : BIO CEO & Investor Conference - New York, NY
-Company presentation - 1:30pm (webcast anticipated)
-Panel discussion with Dr. Missling—Neuroscience at the Crossroads: Late Stage Brain Disorder Pipelines and Unmet Needs - 3pm
-Anavex also listed under Partnering Companies
https://www.bio.org/events/bio-ceo-investor-conference/sessions/628948
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March 13 : 2020 Epilepsy Pipeline Conference - Santa Clara, CA
Dr. Walter E. Kaufmann presenting during the Rare and Ultra-Rare Diseases session on Day 2 - 1:25-3:25 P.M
https://www.epilepsy.com/make-difference/research-and-new-therapies/engagement/2020-epilepsy-pipeline-conference
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May 5-6 : World BI: 16th Clinical Trials Innovation Programme - Boston, MA
Daniel Klamer listed as a featured speaker
https://worldbigroup.com/conference/sixteen-clinical-trials/
(note: the four featured speakers were rotated on conference site) Original four here: https://industryevents.com/events/16th-clinical-trials-innovation-programme-in-boston-ma
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May 20-21 : Protein Misfolding Drug Discovery - Boston, MA
-Presentation: Cross-Learnings from Mechanisms of Action Underlying Protein Conformational Disorders - Dr. Missling, 2:30pm
-Panel Discussion: Conducting a Strategic Analysis of Protein Misfolding Therapeutics - w/Dr. Missling, 2pm
https://protein-misfolding.com/
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June 3-4 : Microbiome Connect Human USA - Boston, MA
Dr. Missling listed as a speaker
https://www.humanmicrobiomecongress.com/events/microbiome-congress-usa-2020-0#speakers
(note: the Agenda available for download is a sample agenda from a previous conference)
Both Missling's 550,000 options grant, and Boenisch's 70,000 stock options grant were accompanied by this Explanation of Responses:
1. The options shall vest upon the achievement of a certain clinical trial milestone with respect to the Issuer's Phase 2 clinical trial program of Anavex(R)2-73 for the treatment of Rett syndrome.
The other 5 were granted 50,000 stock options each and did not include this explanation for the vesting.
I believe the statement you are looking for is from the Q4 conference call, in answer to an analyst's question:
Indeed. Btw, very nice summary post earlier on this topic covering the knowns and the unknowns. I very much appreciate your consistent, evidence-based approach here.
Barring an upcoming PR, we should be just a few weeks off from some clarity between the Q1 report in early Feb and the BIO CEO & Investor conference on 2/11. Seeing that in addition to the panel he is on, and the partnering activities, Missling will be delivering a 15 minute company presentation — I am under the assumption that this presentation will follow past precedent by including both a webcast and a fully refreshed corporate presentation deck. We actually learned some facts about the PDD trial during the course of last year's conference and subsequent interview, and I would hope some of the current unknowns may get filled in this year as well.
More of adding another question to this, but have folks been considering the effect of 30mg and 50mg dosing potentially having been tested in the Australian extension of the original study? Based off of this Anglicare media release from July, that is the case: https://www.anglicare.org.au/about-us/media-releases/new-anavex-trial-for-parkinson-s-disease-to-open-in-sydney/
I realize this isn't official government clinical trial documentation, but it is a very specific thing to mention here and to have be wrong. Perhaps there is some overlap with evidence of enough PDD patients being able to tolerate 2-73 at this dosage level in Australia that it lead the EMA officials to approve of the OLE titration toward 50mg?
It should be noted that Dr. Bezprozvanny originally developed Anavex 3-71 (AF710B) alongside Abaraham Fisher and co-authored much of the subsequent research on the drug. He and his lab at UT Southwestern, who are focused on Neuronal Calcium Signaling, have produced a lot additional sigma-1 receptor focused research over the past few years.
To your point, saying nothing about financial support, but Missling has mentioned on numerous occasions the continued relationship with the MJFF and their influence on the trajectory of the PDD clinical trial.
Missling first mentioned the continued relationship in this interview: https://www.proactiveinvestors.com/companies/news/312195/anavex-life-sciences-advancing-its-parkinson-s-disease-therapy-through-the-pipeline-12195.html
His full statement then was “So we’ve been fortunate, the MJFF funded the entire preclinical studies for Parkinson’s Disease and the data was very promising. And then in combination with the foundation, we decided based on the cognitive data from the Phase 2A Alzheimer’s clinical study that the best way forward would be to combine the cognitive domain element as well as the motor impairment benefit, so that led to the design of the Parkinson’s Disease Dementia, or as we call it PDD, study.”
Then at the ASM shortly after, he again mentioned the involvement of MJFF after the preclinical testing, this time stating; “they said to us that the need was for a PDD treatment”.
He has gone on and mentioned it on other occasions afterwards, and is always keen to thank the foundation. The continued support is also noted with the MJFF logo included in the "Our Partners" section here: http://pddtrial.com/
Also worth noting that the Shake it Up Foundation in AU which is partnered with the MJFF has promoted the PDD trial down there. https://shakeitup.org.au/parkinsons-disease-with-dementia-study-anavex/
To see the Form 4's when searching, you have to change the "Ownership?" selection up top from the default "exclude" to "include".
edit: nevermind, I see that you got them now. Cheers.
Explanation of Responses:
1. The options shall vest upon the achievement of a certain clinical trial milestone with respect to the Issuer's Phase 2 clinical trial program of Anavex(R)2-73 for the treatment of Rett syndrome.
Ha! Check my post 229105. I was disappointed not to get such a response.
Oh, also, an update to the Feb 11 BIO Conference on the list — Missling is also giving a company presentation at 1:30pm. Should be webcast like previous years.
Nice to see that the ERP Biomarker Qualification Consortium’s initial study is now recruiting.
https://clinicaltrials.gov/ct2/show/NCT04025502?term=NCT04025502&draw=2&rank=1
Though I know this list of 2020 Conference appearances will mostly be derided as Dr. Misleading’s Dog and Pony Instagram World Tour Show, I figured some of you might appreciate the look ahead. Happy New Year
February 11 : BIO CEO & Investor Conference - New York, NY
Panel discussion with Dr. Missling—Neuroscience at the Crossroads: Late Stage Brain Disorder Pipelines and Unmet Needs - 3pm
Anavex also listed under Partnering Companies
https://www.bio.org/events/bio-ceo-investor-conference/sessions/628948
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March 13 : 2020 Epilepsy Pipeline Conference - Santa Clara, CA
Dr. Walter E. Kaufmann presenting during the Rare and Ultra-Rare Diseases session on Day 2 - 1:25-3:25 P.M
https://www.epilepsy.com/make-difference/research-and-new-therapies/engagement/2020-epilepsy-pipeline-conference
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May 5-6 : World BI: 16th Clinical Trials Innovation Programme - Boston, MA
Daniel Klamer listed as Featured Speaker https://worldbigroup.com/conference/sixteen-clinical-trials/
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June 3-4 : Microbiome Connect Human USA - Boston, MA
Dr. Missling listed as a speaker https://www.humanmicrobiomecongress.com/events/microbiome-congress-usa-2020-0#speakers
(note, the Agenda available for download is a sample agenda from a previous conference)
Not only was it mentioned in that original PR, but reading in each 10-Q from this past year, when outlining the AD 2b/3 trial, the company states, "The trial is currently taking place in Australia; however, North American sites may also be added."
Now, in the recently released 10-K, that statement has been updated to, "The trial is currently taking place in Australia; however, additional regions are being added."
And at the ASM this past year, Dr. Missling stated that the trial may expand to either North American or European sites depending on enrollment numbers — they are, as always, mindful of resources and won’t need to take this step if enrollment remains good in AU where they get the government rebate.
From these statements, it seems relatively clear to me that the decision was made to add new sites outside of Australia in order to increase the rate of enrollment. It is interesting that in the 10-K, they removed the specific North American mention, but that could indicate setting up sites in both North America and Europe as he had mentioned. We'll see.
Thanks for sharing this update Bourbon. On the new strategic hire front, per Linkedin, Shari Coslett is now the Senior Vice President, Clinical Operations at Anavex. She is an industry vet with deep experience in leading CNS/Pain clinical programs at both major Pharma companies, such as her role as Global Director for CNS at Eisai, and clinical stage operations, like the role she just left at Axovant. Her career bio from her time at Axovant is below:
CTAD update—In addition to the previously shared late breaking oral communication, Anavex and Ariana will also be presenting 2 gut microbiota focused posters:
P90: Gut Microbiota and Response to Blarcamesine (ANAVEX2- 73) in Alzheimer’s Disease Patients: Abundance of Lachnospiraceae and Enterobacteriaceae Families as Potential Biomarker of Response from a 2-Year Study Interim Clinical Data Analysis using KEM Artificial Intelligence
Mohammad AFSHAR (1), Coralie WILLIAMS (1), Frederic PARMENTIER (1), Adrien ETCHETO (1), Christopher MISSLING (2) - (1)Ariana Pharma, France, (2)Anavex, United States
P99: Levels of gut microbiota potentially regulated through anti-inflammatory effect identified as associated to response to Blarcamesine (ANAVEX2-73) in Alzheimer’s disease patients in 2-year Interim clinical data using KEM Artificial Intelligence analysis
Mohammad AFSHAR (1), Coralie WILLIAMS (1), Frederic PARMENTIER (1), Adrien ETCHETO (1), Christopher MISSLING (2) - (1)Ariana Pharma, France, (2)ANAVEX, United States
Previously shared presentation:
P11: Novel analytics framework for augmenting single-arm Phase 2a open label trials with RealWorld external control data: Application to the Blarcamesine (ANAVEX®2-73) study in Alzheimer’s disease matched with propensity corrected patients from Alzheimer’s Disease
Mohammad AFSHAR (1), Coralie WILLIAMS (1), Nanthara SRITHARAN (1), Frederic PARMENTIER (1), Federico GOODSAID (2), Christopher MISSLING (3) - (1)Ariana Pharma, France, (2)Regulatory Pathfinders, United States, (3)ANAVEX, United States
https://www.ctad-alzheimer.com/files/files/POSTER%20PRESENTATIONS.pdf
On accelerated approval, in response to a question, Missling said that he likes the idea and that it will depend on the quality of signal and strength of the data coming out of the current trials. He also made a comparison to an oncology approval that involved a companion diagnostic that I thought was interesting, but didn’t quite entirely catch.
This one’s a while away, but Daniel Klamer is one of the first four “Featured Speakers” announced for the World BI 16th Clinical Trials Innovation Programme, May 5-6, 2020 in Boston, MA. https://worldbigroup.com/conference/sixteen-clinical-trials/
brichnyc, the conference Dr. Missling is presenting at on Friday in Australia is Alzheimer's focused. Info from my previous post:
LATE BREAKING ORAL COMMUNICATION at CTAD on Dec 6th:
On the topic of the Janney presentation, I just took a minute to check 5 other companies who are set to present and of those 5, 4 of them had the same canceled presentation message. Out of 2 companies that I checked who presented today, they both have a message up that their replay is not available due to technical difficulties.
Dr. Missling to speak at the 3rd Microbiome Movement – Gut-Brain Axis Summit in Boston on Dec. 5th - his talk, Sharing Clinical Data that Identifies Gut Microbiota Biomarkers Associated with Improved Clinical Response in Alzheimer’s Disease Patients Treated with ANAVEX®2-73, will be at 11:30am. https://microbiome-gba.com/