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Marion Soto, VP Business Development at Ariana Pharma spoke on a panel yesterday, describing Ariana's process and using their work with Anavex as a case study. Her portion begins at 27:55 and she discusses their work with Anavex at 34:34.
Dec 1 at 4:30pm: LB8 - Top Line Data of ANAVEX®2-73 (blarcamesine) Randomized, Double-blind, Multicenter, Placebo-controlled Phase 2b/3 in Patients with Early Alzheimer’s Disease
(AD) Stephen Macfarlane 1, Timo Grimmer 2, Terence O’brien 3, Edward Hammond 4, Walter Kaufmann 4, Emmanuel Fadiran 4, Christopher Missling 4 1Hammoncare - Melbourne (Australia), 2THU Munich - Munich (Germany), 3Monash University, Alfred Health - Melbourne (Australia), 4Anavex Life
https://www.ctad-alzheimer.com/final-program
Ariana Pharma issued a press release earlier this week regarding the blarcamesine gene pathway data analysis presented at AAIC back in late July: https://www.arianapharma.com/ai-driven-analysis-of-parkinsons-disease-dementia-clinical-trial-reveals-potential-molecular-mechanism-of-blarcamesine-anavex2-73-in-restoring-key-neurodegenerative-pathways/
Dr. Missling's presentation last week:
9/20 - BioAroundWorld 2022 Sept Event: "Cross-Border Healthcare Innovation & Partnership”
https://www.linkedin.com/posts/m%2Es%2Eq%2E-ventures_innovation-healthcare-china-activity-6973989486972018688-bw-i?utm_source=share&utm_medium=member_desktop
Interestingly, in answer to a question, Dr. Kaufmann also speaks toward the probable need for multiple Rett therapeutics as well as the future potential for combination therapies in his presentation to O.R.S.A. last week. Question begins at 45:32:
Yes, and it's great knowing that Missling has acknowledged this in the past. A couple interviews from 2016 where I first keyed into the way he spoke toward the drug combo potential with 2-73. The first is a brief pre-2016 CTAD interview from a Scrip PDF publication that doesn't seem to be available, so I copy and pasted in full here:
Here's a brief, related, editorial from Howard Fillet and Yuko Hara of the Alzheimer's Drug Discovery Foundation from July, with a mention of blarcamesine as one of 3 therapies in phase 3 trials targeting synaptic plasticity or neuroprotection: https://link.springer.com/article/10.14283/jpad.2022.64?fbclid=IwAR1gl4xJKYOdoNsfN_e9gP8TZ5ZSD3GQfii4b0NHbUtd-qio9k2DLCVCqBs
At an Alzheimer’s conference (Alzheimer’s Disease Therapeutics: Alternatives to Amyloid) that I attended in late 2018, Dr. Fillet introduced Dr. Missling prior to the presentations, and made special note of the fact that Anavex was classified under synaptic disfunction, but that Dr. Missling would speak to the fact that 2-73 "probably does a lot more than that". It was also interesting to learn from Dr. Missling that it was Dr. Fillet who first introduced him to Dr. Abraham Fisher, inventor of Anavex 3-71, which lead to Anavex licensing that compound in 2014.
Video of Dr. Kaufmann's presentation and Q&A at the Ontario Rett Syndrome Foundation's AGM last week:
Video of Dr. Kaufmann's presentation at the Rett UK & Rett Syndrome Association of Ireland's Belfast Regional Day on May 21st: https://vimeo.com/719873611
Dr. Missling—along with many other researchers, drug developers, physicians, patients and advocates—will be speaking at this "Fragile X Syndrome: Innovative Approaches to Finding a Cure" webinar on 7/22. Registration is free.
https://wxpress.wuxiapptec.com/events/fragile-x-syndrome-innovative-approaches-to-finding-a-cure/
In addition to the previously reported Rare & Genetic Neurodegenerative Drug Development Summit that Dr. Missling is presenting at today, Anavex also has a presentation at the Access China Biotech Forum - Summer Showcase today.
https://biotochina.org/agenda/
Dr. Kaufmann will be speaking in 2 sessions at the NFXF International Fragile X Conference, on 7/15: Effects of the Sigma-1 receptor agonist blarcamesine in a murine model of fragile X syndrome: neurobehavioral phenotypes and receptor occupancy and on 7/16: Latent profile analysis identifies distinctive cognitive and behavioral subphenotypes in fragile X syndrome
Anavex will also be discussed, amongst other potential therapies, during the Clinical Trials Keynote on 7/15 featuring Dr. Hagerman: Keynote — Clinical Trials in Fragile X Syndrome, with a follow up panel discussion.
https://fragilex.org/get-involved/international-fragile-x-conference-agenda/
Dr. Kaufmann will be speaking about Anavex’s Rett program at the AIRETT (Italian Rett Association) Conference on June 10th:
https://www-airett-it.translate.goog/convegno-airett-2022-il-programma/?_x_tr_sl=auto&_x_tr_tl=en&_x_tr_hl=en-US&_x_tr_pto=wapp&fbclid=IwAR25IQPP4uGIUsof3nNlI3GtQTQZTHzNs9PnnPViNHKSb6PrWJMAgOzQt3k
Fragile X research letter, Brain cell signaling abnormalities are detected in blood in a murine model of Fragile X syndrome and corrected by Sigma-1 receptor agonist Blarcamesine, published today. Full text is behind a paywall. https://onlinelibrary.wiley.com/doi/10.1002/ajmg.a.62853
Related to this, I thought it was interesting that during his H.C. Wainwright presentation this past week, Missling made a point to give a nod to one topic of discussion for the upcoming R&D day. While going over the “Costs Associated with Alzheimer's Treatment…” slide (around 5 minutes into the presentation), he talked about the importance of chronic Sigma-1 activation to aging, then he went on to say: “Also would like to highlight here, you notice that the patients who get earlier Alzheimer’s are females, an interesting situation which we would like to discuss at our R&D day on the 21st of June, why that is so."
Good points. That's my impression too. I believe he referenced ml's of dosing and not mg's. Knowing the volume of liquid solution alone wouldn't allow us to draw any definitive conclusions on the amount of active drug dosed.
PDD news next week. Anavex will have a poster presentation at AD/PD 2022, March 15-20:
I'm not sure what you are getting at. I was just pointing out the company communicated extension of the original OLE and some timeframe observations I had made through social posts that I thought you might be interested in. Apologies if it came off another way.
The initial 12 week OLE was expanded to at least 36 weeks. See the footnote on pg. 21 of the current corporate presentation: https://www.anavex.com/_files/ugd/850d88_5640fe64cca344d79217bedd6b8b5a2e.pdf
From some social media sleuthing, there was a bit of delay in getting that going (awaiting regulatory approvals? by design for delayed dosing? idk), but some women started the 36 week US Rett OLE this past summer and should be wrapping up around now.
Fair enough, and I appreciate the reply. Personally, I tend to view the significant funding to be a rather prudent and timely move when facing the potential of a solo rare disease drug launch, but of course I can see how it could be viewed/utilized otherwise. I have no qualms with your 3 scenaris post, and appreciate maintaining a level approach. Cheers.
5 Clinical Trial Readouts in Neurology to Look for in 2022
https://www.neurologylive.com/view/5-clinical-trial-readouts-neurology-to-look-for-in-2022
Link is in the post; https://scienceofparkinsons.com/2022/01/20/road2022/ . It's Dr. Simon Stott's personal blog for communicating about Parkinson's research in an easily understandable manner. He is the Deputy Director of Research at Cure Parkinson’s https://cureparkinsons.org.uk/people/dr-simon-stott/ and has written about Anavex's efforts on several occasions.
Incredibly exhaustive post from Dr. Simon Stott on his “The Science of Parkinson’s” blog covering the full 2022 landscape of clinical research focused on disease modification for Parkinson’s. Great to see his continued enthusiasm for blarcamesine in this write up: https://scienceofparkinsons.com/2022/01/20/road2022/
Nice, brief Alfred Health promotional video from December describing their clinical trials efforts. Out of all the clinical trials they run (over 300 open), across many different health conditions, in this video they chose to briefly feature a Rett syndrome patient, Alana, who participated in the AVATAR trial (note, Anavex/2-73 is not named in the video but it is their only current Rett research). Pretty cool to see, particularly when being introduced in the context of potentially transformational new treatments and followed by commentary on how clinical trials can be a life changing experience for patients and their families.
March 11: Rett Syndrome Externally-Led Patient Focused Drug Development Meeting
https://rettpfdd.org/?fbclid=IwAR2zXbhSrmJ4m8awcLIa6lUsUG2g2mDkECEiYb2zkjsAy09AxNRU7MXQ3ic
A couple recent perspective/review articles of interest:
An Update on Psychopharmacological Treatment of Autism Spectrum Disorder
https://link.springer.com/article/10.1007/s13311-022-01183-1?fbclid=IwAR2dYSw9_ulEwNlufoBzSziNR5odeh-KiwNqGQv7OZaSLJGX_ZyVRUaTKSU
Fragile X premutation review article published today and co-authored by Dr. Hagerman: https://www.dovepress.com/fragile-x-premutation-medications-therapy-and-lifestyle-advice-peer-reviewed-fulltext-article-PGPM
JJ, as you know Missling presents at numerous conferences without ever PR'ing them throughout the year. Maybe those presentations can be considered nothing burgers because they don't contain publicly disclosed new material information, but I track them with interest to gain awareness of what is being discussed and with whom.
When I first posted Wednesday's conference description in early September — https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165805267 — I thought it would be a great time to coincide with AVATAR data based on the date/topic, but realized in and of itself, this conference and the synopsis of Missling's presentation in no way indicate that new data will be shared.
I do think there's a possibility we hear something this week prior to the conference, but also would not be at all surprised if the conference were to pass with no mention from the company at all.
"Exploring SIGMAR1 Modulators for the Treatment of ALS", presented by Nell Rebowe of Anavex Life Sciences at the 4th Annual ALS ONE Research Symposium:
Information on the ALS conference: https://2021alsoneresearchsymposium.splashthat.com/
They presented at this same conference, "the company's preclinical data and rationale for Sigma-1 receptors for the treatment of ALS" last year as well: https://2020alsonesymposium.splashthat.com/?fbclid=IwAR3iuG6T5KQtiyO6KyybhXSEP-vygw8U7PI2lsl67D1hEq_PPc452A7yB44#g-909773350
Dr. Barrie Pittock was featured on his aged care/retirement community website and Facebook page last week. Nothing new about the AD trial here, but having been one of the first to enter the trial in 2018, after being diagnosed with AD in 2014, it’s nice to see him featured here (in addition to the occasional letters to the editor he pens):
https://www.mayflower.org.au/news/latest-stories/meet-nobel-prize-winner-dr-barrie-pittock/?fbclid=IwAR2d2lbcg1E2BWW9fVzYSRYs54Zy9gziV7l-CLvoOI64ONMjOA6qBHLZN3Q
From 2018: https://www.abc.net.au/news/2018-09-25/alzheimers-disease-research-questions-plaque-as-cause-of-disease/10299514
Ha! Would share if I found anything concrete, but here's some pure speculation. This MJFF virtual 2 day webinar, Innovating from Drug Discovery through the Clinic: Novel Approaches to PD Therapeutic Development, next week looks like it would be a great venue for additional PDD info/news on upcoming trials. The day 2 description caught my eye (though of course not banking on an appearance) https://www.michaeljfox.org/parkinsons-disease-therapeutics-webinars?os_cid=tw-a1b1R00000AE7tR :
CNS updates: Anavex’s CNS drug slows progression of motor and non-motor symptoms in Parkinson’s disease
— Jenny Roger (@SuzannahWinters) July 31, 2021
To know more join our conference: https://t.co/ebS1XibAbt#cns #braindisorder #spinalcord #Parkinsons
Some information about the imminent start up of EXCELLENCE clinical trial sites in the UK, starting around the 52:28 mark here:
I agree. I've been impressed with their approach and achievements to date. I first took note of Cognetivity earlier this year after Anavex advisory board member and CTAD PDD data presenter, Dag Aarsland, joined their advisory board back in March: https://cognetivity.com/renowned-geriatric-psychiatrist-professor-dag-aarsland-joins-advisory-board-at-cognetivity-neurosciences/
It was available when I posted, but set to Private a few minutes after the presentation ended. Maybe wasn't supposed to go live until 1:30 as Steady_T pointed out?