Anavex. Ny tråd - marts 2024.
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Lige lidt som er hapset fra en Anavex gruppe på Messenger =
Hi, I got permission from a friends take to release his notes. Cheers.
They are calling themselves a regulatory stage CNS company.
Patients are peeling off of Trofinetide, and patients on Blarcamesine, through compassionate care schemes, are continuing on the drug. FDA gave them feedback on RETT to run another phase 3 trial because it would be unfair to Acadia (Trofinetide) who had a drug approved on a successful phase 3 trial if drug was approved despite missing statistical significance on endpoints. They are at a RETT conference concurrent with the ASM, to present a new trial (12 week), in which they will enroll 2x patients (~150) on a 1:1 ratio.
Saw a picture of the pill. It's a clear capsule with branding on the coating.
They have not met with fda on Alzheimer's because of the missed ADL, but now with the new draft guidance and bio-markers, and black box warning and failure of MAB uptake, feel much more confident to talk with them. When asked if European approval would be first and FDA second, he answered not necessarily because though they started with EMA, FDA is much quicker.
When asked about long-term efficacy, he said they have good data and RWE of AD patients on drug for 146 weeks. They have not seen any of the ATTENTION data on the OLE. When asked if FDA will accept aBeta as a biomarker using blood plasma, he said many companies have now adopted this method. On brain atrophy data, he used the following language (attenuated, stopped, delayed). He did not give any ground on timeline for EMA submission or peer review, but held to by 'end of year' though he conceded this was playing it safe, which I interpret as meaning it may happen earlier. We saw some new slides, one in which they do a much better job illustrating their drug vs the MAB's, comparing their downstream approach to the upstream approach of activating the sigma-1 receptor, emphasizing Autophagy. In my opinion, focusing on Autophagy, is smart because it gets lots of headlines in health news as it relates to intermittent fasting and other trending health fads regarding cell health.
They have completed part A of Schizophrenia trial which was a dosing study and have now started part B. When asked about delays with PD/PDD, he answered strongly that major advances were being made in PD biomarkers, and testing doesn't just come off the shelf at 'Amazon' as he put it, they are being developed, and thus they are waiting because they feel they can run a more effective trial with them. He used the 2b/3 AD trial as an example, suggesting at the time they initiated that trial, the biomarkers they were testing for were not at all common then, but are now common in most AD trials. His comments seem to be pointing toward the new alpha-synuclein biomarker discovered by the Michael J Fox foundation last year.
In a question asked about partnering versus buyout, he first responded by saying that a buyout is an extreme form of partnership and at the other end of the spectrum was doing everything themselves. He indicated he was open to all options, with the criteria that it would be whatever was in the best long term interest of shareholders.
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Og lidt mere =
As I suspected, the PD trial has been delayed for very good reasons and has increased in size and scope. I'm also glad all my donations to MJFF over the decade have been fruitful.
"When asked about delays with PD/PDD, he answered strongly that major advances were being made in PD biomarkers, and testing doesn't just come off the shelf at 'Amazon' as he put it, they are being developed, and thus they are waiting because they feel they can run a more effective trial with them. He used the 2b/3 AD trial as an example, suggesting at the time they initiated that trial, the biomarkers they were testing for were not at all common then, but are now common in most AD trials. His comments seem to be pointing toward the new alpha-synuclein biomarker discovered by the Michael J Fox foundation last year. "
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Marwan præsenterer på AAIC 2024.
https://alz.confex.com/alz/2024/meetingapp.cgi/Paper/90729?fbclid=IwZXh0bgNhZW0CMTEAAR1MP0o5N3dR9BAZbGnZYacHDrM7bf6srP5jc70-_QSAf3nhOyioZR5UVPo_aem_S_woPgqgHxzSYD7Cfiyq-QDet bliver interessant.
Han kan måske slippe katten ud af sækken
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1,5 times præsentation af dr. Marwan Sabbagh, Fmd for scientific board.
Bedre kan vi ikke ønske. Husk at han sagde, at der vil komme overraskelser i år (video lagt op tidligere i denne tråd)
Det kan være det event som Missling omtalte, hvor AD-data eller dele blev offentliggjort, hvis ikke peer review kom før.
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Anavex Det er det helt rigtig sted og præsenteret af den absolutte helt rigtige mand!
Tror dog ikke at han har mere end 15 min. - Anavex er en blandt flere, der skal præsenterer indenfor den 1 1/2 time.Marwan Sabbagh er en af de største og mest anerkendte kapaciteter inden for Alzheimer!
Har lyttet til flere videoer med ham, og det er tydligt, at han med hans enorme viden brænder for området og især med patienterne i fokus.
Det er også vigtigt, at han er uafhængig og han først blev tilknyttet Anavex efter AD fase 2/3 TLD december 2022, som formand for den eksterne ekspertgruppe.
Tror folk vil lytte meget mere til Marwan Sabbagh end Missling.
Marwan Sabbagh, MD, FAAN
Marwan Sabbagh, MD, is a behavioral neurologist and the Moreno Family Chair for Alzheimer's Research in the Alzheimer’s and Memory Disorders Program at
Barrow Neurological Institute (www.barrowneuro.org)
Om Peer Review udkommer før eller efter, så må indholdet af præsentationen på AAIC omfatte de væsentligste resultater fra AD forsøget inklusiv også Blarcamesines evne til at bremse tabet af hjernevæv mm.
Dette må absolut rykke ved kendskabet til Anavex og deres videnskab.
Det store spørgsmål er, hvem vil sælge 22 mill. aktier til shorterne inden den 28. juli - de får ikke mine! -
Annovis får 45 min. Lad os håbe på en meddelelse i morgen fra Anavex.
https://irpages2.eqs.com/websites/annovis/English/431010/us-press-release.html?airportNewsID=5e475079-6c3c-4870-a24b-185541a98119 -
Det ligner 12-15 min.
Men lad os håbe, at de data vi er blevet lovet kommer indenfor de næste måneder. Mon der er late breaking på den konference ?
Annovis er helt sikkert mere inde i varmen end Anavex og de har også et spændende stof. Jeg tvivler dog på, at det har en langvarig effekt. De ødelagde dog deres seneste forsøg men en katastrofal forsøgsoptag. Mange pts havde ikke AD.
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Anavex Har et frimærke i Annovis, men synes ikke de har kørt deres fase 3 forsøg særlig professionelt. Det viste sig f.eks. efterfølgende at hele 115 af de indrullede patienter slet ikke havde Alzheimer og derfor ikke kunne regnes med i forsøget? På Anavexs GF, nævnte Missling, at alle deres patienter var grundig blevet testet, at alle med sikkerhed havde en Alzheimer diagnose - med utvetydig henvisning til Annovis.
Til gengæld har Annovis været bedre til at opdaterer end Anavex - hidtil.Kun Jin fra Anavex har forresten også en præsentation den 29. Juli på samme AAIC, omhandlende forbedrede værktøjer til at analyser data.
Ja hvis Missling fremover vil være mere informativ overfor aktionærerne, som han lovede på GF, så må der absolut komme en PR med som minimum deltagelsen på AAIC.
I forbindelse med AD, så ville Anavex også præsenterer RNA data denne sommer - havde indtrykket af, at dette var en særskilt præsentation.
Igen - er i den forbindelse ekstrem glad for, at Marwan Sabbagh ser ud til at få en mere fremtrædende rolle fremadrettet!Der skulle også være noget information fra RETT konferencen, som åbenbart først sluttede i går lørdag. (Der skulle angiveligt kun have været sølle 2 patienter fra placebogruppen, som ødelagde p-værdien, så denne ikke kunne holde sig på 0,05, men endte på 0,06!)
Man ville også på en konference offentligøre information om fundet af en meget vigtig, målbar klinisk biomarkør, som var en meget vigtig fællesnævner på tværs af Fragil X patientgruppen.
Udfordringen med designet at et Fragil X forsøg, er bl.a. den store variation i symptomer i patienterne - nu lader det til, at Anavex har knækket koden?Vedr. Parkinson fase 3 forsøget, så skulle Anavex også have opnået store fremskridt for et optimeret design med klare biomarkører.
Så alt i alt udsigt til stor aktivitet de næste mdr., som på alle måder peger på en meget lys fremtid for hele casen!
Måske løfter de allerede på torsdag den 27. juni på HC Wainwright lidt af sløret om, hvad der er i vente?
https://finance.yahoo.com/news/anavex-life-sciences-present-h-113000764.html
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Helt korrekt med Annovis. Hvorfor jeg tror de er mere inde i varmen er, at de har kørt forsøg i US og blevet sponseret stort fra NHI (som jeg husker).
Ja det ser ud til at komme alt det vi har ventet på.
Ærgeligt mht rett. Havde de blot lavet 1:1 randomisering så havde vi været i $20-30.
Just a matter of time. But when
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Fantastiske opdateringer, Tasso og Solsen, lad os håbe at det er et vendepunkt. Jeg valgte i tirsdags at supplere yderligere op i Anavex, da jeg fik flyttet en ratepension hos Velliv fra tidligere arbejdsgiver og over til egen ratepensionskonto hos Nordnet. Nu må det vende.
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Jeg har netop lyttet til Annovis's seneste investor presentation... Enig at Dr. Maria Maccecchini er meget bedre i hendes kommunikation. Hun formår at forklare sit stof på en relativ simpel og forståelig måde....MEN... jeg bliver efterladt med en "trial and error" eller "Let's do it, then we learn from the result"... både ift deres seneste forsøgsoptagelse (40% af de rekrutterede ikke har AD) eller hypotese for deres næste test.
Spændende at følge med, men jeg har endnu ikke en god mavefornemmelse for at hoppe i.I øvrigt, nogle ved noget om APOE4 (3 eller 2) som hun snakker om. Hun nævnte noget med 100% patienter med APOE4 har AD, men hvor stor en procent af AD har APOE4?
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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3726719/
The human APOE gene exists as three polymorphic alleles-e2, e3 and e4-which have a worldwide frequency of 8.4%, 77.9% and 13.7%, respectively.However, the frequency of the e4 allele is dramatically increased to ~40% in patients with AD.
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Falconer66a har skrevet følgende indlæg på ihub som gjorde et stort indtryk på mig omkring de fejlede ADL data; så synes jeg ville dele hans indlæg her:
Afalconer66a Free
17 minutes ago
Post #462,294
Re: #462,276: @georgejjl - When I initially read the p value of
Blarcamesine Didn't Fix Patients' ADLs. Does It Matter?Yes, the trial results from blarcamesine being tested in early-stage Alzheimer's disease showed significant statistical significance for three of the four matters being assessed. Meaning, that for those three Alzheimer's problems the drug provided significant therapeutic outcomes. For them, the drug works, safely.
But blarcamesine didn't achieve, even closely, statistical significance on the "ADL" test. It had a reading of p=0.234. To be statistically significant, meaning that the result was authentically therapeutic, not some random-chance result, the p-value had to be p=0.05 or less. The blarcamesine against early-stage Alzheimer's ADL factor failed miserably; way too high, nowhere near 0.5 or less.
Should this matter? Does blarcamesine's ADL treatment failure indicate that the drug should not be approved as a treatment for early-stage Alzheimer's? It's important to consider what, in medical practice and research, "ADL" is: "activities of daily living."
Consider them:
Common activities of daily living (ADLs) include feeding oneself, bathing, dressing, grooming, working, homemaking, and managing personal hygiene after using the toilet.I have extensive personal experience with the problem. Over about 10 years my father suffered and finally died of medically-diagnosed Alzheimer's disease.
For the first 6 or 7 years he had virtually no "ADLs." As it happened, my mother was an experienced registered nurse in a recognized neurodegenerative and brain-injury clinic. She knew the symptoms, course, and sequellae of Alzheimer's patients. She was a medical professional who cared for such patients. She knew what Dad had, and how it would end up.
Simply, as is the case with virtually all early-stage Alzheimer's patients, the recognized "activities of daily living" of my father were essentially unhindered. Cognitively, he very slowly became compromised; having to give up and sell off his accountancy practice. But he didn't suffer from diminished daily activities until much later, when he had to be institutionalized.
What might have happened if Dad could have been treated with blarcamesine at the very earliest point, when medical testing of cognition showed what he had; and what was to come?
As others have mentioned, testing for drug efficacy against ADLs in early-stage Alzheimer's patients yields no useful information. Simply, activities of daily living aren't compromised at the start of Alzheimer's - at the stage where blarcamesine will be therapeutically most effective.
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Anavex Netop samme erkendelse er FDA også kommet til, hvor de i deres nye guideline for kriterier for at få nyt medicin godkendt til behandling mod Alzheimer, ikke behøver at eftervise effekt i ADL - har endnu større tillid til, at EMA også vil tillægge samme lille betydning af ADL i den kommende ansøgning fra Anavex.
Har personligt som tidligere beskrevet, oplevet tilsvarende udvikling hos et nært familiemedlem, som Falconer66 beskriver.
En Alzheimerpatient kan klare sig udmærket i de daglige gøremål i flere år, men hvor udviklingen af demens bliver mere og mere udtalt - og det reelt er dette, der sætter en stopper for, at vedkommende f.eks. ikke kan forsætte med at bo i egen bolig. -
Marwan Sabbagh chairs Novo Nordisk sponsored symposium på AAIC 24
The Future of Care for Alzheimer's Disease: Breakthroughs and Beyond
Tuesday, July 30
12:30 - 1:45 p.m.
Philadelphia Marriott Downtown (Grand Ballroom G-L)At AAIC
2024, we are thrilled to bring together a panel of leading experts from clinical practice, research, and a patient organization for the symposium, The future of care for Alzheimer's disease: breakthroughs and beyond. Professor Marwan Sabbagh will chair the expert faculty panel in exploring recent diagnostic and therapeutic developments in the Alzheimer's disease (AD) landscape.
Corporate-Sponsored Symposia | AAIC | Alzheimer's Association
Corporate-sponsored symposia provide clinicians, researchers and dementia care professionals the opportunity to learn more about important topics and ideas.
Corporate-Sponsored Symposia | AAIC | Alzheimer's Association (aaic.alz.org)
Og tusind tusind tak til alle jeres input. Jeg har været en ivrig læser.
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Anavex Siger lidt om Marwan Sabbaghs anseelse inden for Alzheimer, at han skal være "formand" for ekspertgruppen på AAIC.
Mon ikke også han vil komme en del ind på Blarcamesine og hele Anavexs tilgang?
Det ville være en naturlig forlængelse af hans præsentation af data fra samme for Anavex den 28. juli.
For et par uger siden nævnte han på en anden uafhængig præsentation Blarcamesine, som en af to stoffer, der hidtil var ret ukendt og som ville overraske Alzheimerverden med deres tilgang og resultater.En spændende detalje, at vores egen Novo Nordisk er sponsor for præsentationen!
Hvem ved deres fulde fem tør shorte Anavex på nuværende tidspunkt?
Anavex har hidtil nok begået en af deres største kup, ved at have fået tilknyttet dr. Marwan Sabbagh - dette må tildels kunne tilskrives Missling, men også at resultaterne for Blarcamesine har været gode og tilstrækkelig overbevisende til, at kunne tiltrække en så stor kapacitet til lille Anavex! -
Annovis kommer med resultat for deres PD forsøg inden for næste par uger. Det står både på deres hjemmeside og blev nævnt af deres CEO i investor presentation for ca. en uge siden "will arive in 2 weeks time and hopefully good result..."
Parkinson's Study
We conducted a Phase 3 study in early Parkinson's patients, with a total of 471 patients completed the trial in the US and EU. The last dosing was completed in December 2023, and we expect to announce results in June 2024.
Hvad tænker I?Annovis næste skridt er at teste molekylens "langsigtet" virkning både på AD og PD. Er det ikke noget man bør have designet ind i forsøgerne inden man afslutter fase3?
Det ser ud til at de arbejder inden for ca. samme sygdomme som Anavex.
Jeg har svært ved at finde frem til en gode materialer som beskriver mekanismen bag Buntanetap. -
Der findes ret meget materiale, der redegør for tesen bag Buntanetap (Posiphen) i behandlingen af AD/PD, fx
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8708689/
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