ANAVEX NY TRÅD JULI - PRÆVENTIV BEHANDLING AF ALZHEIMER!!!
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Nu kunne det være et belejligt tidspunkt at få en af de Peer reviews vi har i restordre, og selvfølgelig med positiv bedømmelse.
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Anavex. Oversigt kommende begivenheder i 2021-opdateret.
Udmelding fra FDA vedr. Parkinson fase 2 forsøget.
Udmelding fra FDA vedr. RETT US fase 2 forsøget.
Peer Review Parkinson. (Evt. lig med fuld datapakke?)
Peer Review RETT. (Evt. lig med fuld datapakke?)
Resultater fra 3-71 FTD fase 1 forsøget.
Fuld indrulning RETT + 18 år fase 2/3 høj dosis.
Fuld indrulning RETT 5-18 år fase 2/3 optimeret dosis.
Afslutning Parkinson OLE 48 uger okt. 2021.
Opstart Fragile X fase 2/3.
Opstart Parkinsion image forsøg med MJFF.
Opstart ubenævnt sjælden indikation fase 2/3.
Topline resultater RETT + 18 år fase 2/3 høj dosis.
Resultater fra ERP forsøget skizofreni i konsortie regi.
Opstart fra ERP Ketamin forsøget i konsortie regi.
Q2 start august.
Q3 start november.
2-3 CC'er med præsentation af PDD og RETT mm.
Evt. endelig tildeling af ansøgt patenter.
Resultater vedr. nyt præventivt AD forsøg - opstart fase 3.
Øvrig udmelding fra myndigheder FDA, EMA, TGA.- det løse og uforudsete.
Suppler gerne!!!
Anavex skal godt nok til at have gang i nyhedssprøjten, hvis de skal nå alle disse ting - udover disse uforudsete nyheder.
Enkelte af dem kan nemt give 30-40 % på kursen - hvis positive.
Der sker bare ekstrem meget bag lukkede døre og det er helt tydeligt, at FDA er med ind over mange af disse processer.
Som I skriver længere oppe, har dagens fald intet med Anavex casen at gøre - dette er en segment korrektion af de kunstig opkørte kurser i især SAVA, ANVS mm.
Anavex casen er langt mere veldokumenteret og langt bredere funderet end i bl.a. ovennævnte selskaber - og så virker skidtet stadig og uden bivirkninger - ellers ville FDA heller ikke gå med til et nyt stort fase 3 forsøg for undersøgelsen 2-73s præventive effekt i Alzheimer, hvis bivirkningsprofilen ikke var tilfredstillende.Nuværende kurs er da lidt træls at kigge på, men er helt overbevist om, at vi meget snart får vendt trenden igen.
Vi skal bare have sat gang i ovenstående lovede nyhedsstrøm! -
God morgen fra Thailand,
Av-av det var brutalt at vågne op til men ANVS & SAVA's meget store MC's i forhold til hvor langt de er, har intet holdepunkt så kan ikke rigtigt sige at det var overraskende som nævnt af Tasso i tidligere indlæg.
Monthly fool artikel om alle 3 selskaber, han sviner dem alle til, også Anavex hvori han bla skriver:
Today's flop was a harsh reminder that Anavex Life Sciences has been testing its lead candidate, blarcamesine, in different forms of dementia for over a decade, and the company still hasn't shown evidence that it significantly reduces cognitive decline for Alzheimer's disease patients, compared to a placebo.
Naa det er jeg ikke enig i, han har ikke fuldt ordentligt med, dårlig researched artikel:
Here's Why Annovis Bio, Anavex Life Sciences, and Cassava Sciences Sank on Thursday | The Motley Fool
A clinical-trial flop for Annovis Bio is reminding investors that developing new drugs for Alzheimer's disease is an extremely risky business.
The Motley Fool (www.fool.com)
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Jones Trading's 5 stjernet analyst Soumit Roy vedligeholder et køb på Anavex og stadig kurs mål på 50$.
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Super dygtige MayoMobile fra IHub har lavet en rigtig god opsummering efter data kom ud fra ANVS & SAVA i går:
MayoMobile Thursday, 07/29/21
Post 323457AAIC 2021 Updates & Anavex's 29 July 2021 PR
Annovis
First let's talk about Annovis (ANVS) data. Presented on 28 July 2021, ANVS failed to impress with lackluster outcomes and even worst slide-ology (as we call it). As a reminder, this trial was for Alzheimer's disease and Parkinson's disease, and was administered via IV. Before we dive into it, let's acknowledge that their baseline MMSE score for the AD cohort was 24.5 - 25.4. This means the vast majority of their patients are MCI or very early-stage Alzheimer's disease. Keep in mind that Anavex's AD 2a MMSE baseline was 21 at the beginning of the trial, which indicates Anavex's cohort was significantly more degraded than Annovis'. This is an important distinction because most trials see better results in less-impaired patients. If ANVS is disease-modifying, their scores should have blown Anavex out of the water on this fact alone.
ANVS Summary: ANVS grasped at straws with 7 different cognitive tests out of all 7, only ADAS-COG 11 dosed vs. baseline produced statistically significant results (with a 4.4 point improvement from baseline/30%). They failed to produce statistically significant results in ADAS-COG 11 for dosed vs. placebo (dosed improved 3.3 points/22% vs. placebo, indicating placebo managed to improve 8% on their own in the same amount of time - 25 days). Their PD patients were tested using UPDRS which did show trends of improvement, none of which was meaningful. Considering ANVS's high MMSE baseline, vast slew of cognitive tests, and less intensive ADAS-COG 11 measure, (as opposed to ADAS-COG 14), ANVS should have been able to provide dramatically better data for both Alzheimer's disease and Parkinson's disease. Their ADAS-COG 11 outcome must be looked at skeptically as they failed to produce significant results against placebo. Safety profile was great. More time and data is needed to reevaluate at a later time.
ANVS Breakdown: ANVS tested 4x separate ADAS-COG measures (ADAS-COG 3, 6, 11, and 14) with ADAS-COG 11 being their primary cognitive endpoint. Intriguingly, ANVS was only able to garner statistically significant results against baseline, but NOT for placebo for ADAS-COG 11. Furthermore, all other ADAS-COG tests failed to reach statistical significance. Slide 8 demonstrates how ADAS-COG 11 is relatively less intensive than ADAS-COG 14, which is likely why the company chose it to begin with, in order to try to inch out statistical significance.
UPDRS data for the PD cohort was abysmal:
UPDRS Part 1: Placebo improved 14% compared to 23% dosed
UPDRS Part 2: Placebo improved 26% compared to 27% dosed (nearly identical)
UPDRS Part 3: Placebo declined 1% compared to 2% improvement dosed
UPDRS Part 4: Placebo declined 11% compared to 7% decline dosed
UPDRS Total: Placebo improved 1% compared to 3% improvement dosedTo put the Parkinsons's UPDRS data into perspective, ANVS trialed for 25 days. Meanwhile, over 14 weeks Anavex's UPDRS total score was: placebo declined 3.53 points and dosed improved -10.98% for a total placebo/dosed differentiation of -14.51 points, an 18.9% improvement. A -7.1 point improvement is considered clinically meaningful. Anavex surpassed that by over double, ANVS didn't even come close.
Furthermore, ANVS failed to produce statistically significant or clinically meaningful data in the WAIS coding test, MMSE, and CDR sum of boxes. There is some promising correlation however, which may be proven out in a longer trial.
The last item of note for ANVS was their ability to reap statistical significance in inflammatory markers in AD and PD patients. This is overall a positive but doesn't necessarily mean anything if their cognitive outcomes can't follow up with meaningful data.
Cassava
Cassava's (SAVA) 9 month AAIC data is actually quite favorable to the company. The first 50 patients (data presented) had a mean MMSE baseline of 22.6 - somewhat less impaired than Anavex's AD 2a, but relatively comparable.
SAVA Summary: Overall the cognitive results for SAVA are quite favorable. At 6 months they were able to produce a -1.6 point ADAS COG 11 improvement (10%) to baseline and a -3.0 point ADAS COG 11 improvement (19%) at 9 months. What's more, at 9 months 66% of patients improved over baseline. To top off their good cognitive results, the dose is given orally, the trial appears to be safe, and they had some titillating biomarker data.
SAVA Breakdown: As mentioned earlier, SAVA was able to produce very nice ADAS-COG 11 improvements at week 24 (6 mo) and week 36 (9 mo). The improvement to that point cannot be understated; however, as a word of caution, it is important to note that many companies do well in early phases of their AD trials with a drop off typically occurring sometime at or before week 40 - 60. One of the reasons this knowledge is so important is when we account for Anavex's long term AD 2a data. Let's compare them below.
ALL POINT VALUES ARE ADAS-COG/CORRELATED VALUES
SAVA 24 week (6 mo): -1.6 point
SAVA 36 week (9 mo): -3.0 point
BASELINE MMSE was 22.6AVXL 57 week (14.25 mo): -3.4 point
AVXL 70 week (17.5 mo): -5.1 point
BASLEINE MMSE was 21Additionally, it should be noted that the relatively large N Anavex PDD trial yielded significant results in Episodic Memory outcomes, which have a 70% correlation to ADAS-COG. The 29 July 2021 PR makes sure to calculate those correlations for us.
AVXL PDD 14 week (3.5 mo): -1.9 point in the 50mg cohort (8% mean improvement over baseline).
Not to mention the massive 4.0 difference between dosed and placebo at week 14 in the PDD trial.
Back to SAVA, the company was able to reduction in a number of cerebral spinal fluid biomarkers.
AB42: low in AD patients (increased 84% at 6 mo)
Total tau: marker of neurodegeneration (decreased 38% at 6 mo)
P-tau181: marker of disrupted tau function (decreased 18% at 6 mo)
Neurogranin: synaptic loss/degeneration (decreased 72% at 6 mo)
Neurofilament Light Chain: axonal loss/degeneration (decreased 55% at 6 mo)
YKL-40: marker of neuroinflammation (decreased 44% at 6 mo)
sTREM2: microglial-induced neuroinflammation: (decreased 65% at 6 mo)
HMGB1: pathogenic "danger" molecule: (decreased 53% at 6 mo)Finally, for their behaviors endpoint (NPI): "at baseline, 34% of patients had no neuropsychiatric symptoms on the NPI scale. At month 9, >50% of patients had no symptoms on NPI". So the company was able to reduce NPI to 0 for about 16% of affected patients.
Summation: Annovis and Cassava are both showcasing phase 2 AD trials. Annovis has a lot of ground to make up for in their phase 3 trial. Current Annovis data lacks teeth and presents a number of holes towards its potential. Additionally, Annovis is administered via IV, and their starting MMSE was considerably higher than both AVXL and SAVA - which should have produced a much better outcome. Cassava data is quite compelling. Longer term data with a placebo control and blinding is needed to corroborate these results, but if I had to choose between an investment in Anavex, Cassava, and Annovis, I would invest capital in that order. While Cassava's data looks as good as Anavex's in many ways, we must remember that Anavex's data has held over a long time horizon. Anavex has learned a lot from the AD 2a trial and has positioned themselves very well to have an even greater effect in the ongoing 2b/3 with less impaired patients, biomarker/genomic indicators, and dosing understanding. The 2b/3 cognitive data will likely be significantly greater than their 2a - and we didn't even mention their ADCS-ADL daily living scores which were extraordinarily powerful. Furthermore, unlike its competition, Anavex has extremely significant PDD data, and is likely nearing approval and commercialization in Rett Syndrome.
Anavex 29 July 2021 Press Release
Anavex surprises shareholders by announcing plans for a phase 3 trial to prevent Alzheimer's disease. The company has been making comments about this potential for months now with a very public proclamation days ago on a Yahoo Finance interview with the CEO. It is extremely interesting this trial is already being planned, as most shareholders would probably have assumed it would have happened post-AD therapy approval. It is fantastic news the company is sparing no time (and newly acquired cash) to expand the pipeline even further. I look forward to seeing more preclinical preventative data later this year (having already seen signs of prevention in clinical trials, and other preclinical trials). As a final note and mentioned earlier, the company has provided the ADAS-COG correlations for not only the Alzheimer's 2a trial, but also the recent PDD cognitive data, and this is to my knowledge the first time the PDD calculations have been readily provided to investors.
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Desværre tror jeg at ugens AAIC 2021 præsentationer har været medvirkende til at forstærke den generelle skepsis, der blandt bioanalytikerkorpset/journalister er/har været over for at der er nogen, der vil kunne "knække koden" og præsentere AD/PD resultater i form af reelle kliniske forandringer. Motley Fools wrap up giver et ret godt indtryk af denne skepsis, se nedenstående
https://www.fool.com/investing/2021/07/29/heres-why-annovis-bio-anavex-life-sciences-and-cas/?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article -
Undskyld. Jeg havde ikke set, du havde refereret til MF artiklen. Uanset om indholdet er korrekt eller fejlfyldt, så udtrykker den nok desværre, de forventninger/opfattelser, der p.t. findes blandt WS healthcareanalytikere/journalister vedr. mulighederne for at nogen vil kunne fremvise reelle kliniske behandlingsresultater, og dermed en mulig forklaring på den ret vodsomme markedsreaktion, man var vidne til igår, hvor volumen i SAVA var 10x average, ANVS var 7x og AVXL ca. 2x, og udløste fald i kurserne på mellem ca. 15% og 60%.
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Anavex. Brug af 2-73 præventivt understøttes af denne uafhængige Peer Review fra den 14. juni 2021.
The authors conclude, that in the future it may be the case that SIGMAR1 ligands (or drug combinations) targeting the activation of autophagy, and other SIGMAR1 related neuroprotective pathways, are prescribed prophylactically, in much the same way as with statins for the prevention of heart disease today in an effort to prevent the loss of the SIGMAR1 receptor seen during AD.
( Prophylacticallly = præventivt )
Det er ikke kun Anavex, der har set denne præventive mulighed!
Dette nye fase 3 forsøg bliver relativ omfattende, med flere tusinde patienter, hvor man over en længere periode - måske 3 - 5 år vil følge raske, men potentielle emner i en Alzheimer risiko gruppe - nogle med 2-73 i høj/lav dosis og så en placebogruppe.
Mener ikke et lille selskab som Anavex, med begrænsede midler, ville sætte et sådan forsøg i gang, uden at have set meget overbevisende data.
Man ville heller ikke risikere at underminere igangværende andre forsøg, hvis man var det mindste i tvivl om den gode bivirkningsprofil.
FDA er jo også med inde over processen med de forbehold de måtte have!
Et sådan forsøg er heller ikke billigt - så Anavex må mene, at det er det værd ifht. muligheden for at køre andre forsøg for de samme penge.Omfanget af casen gør det mere og mere sandsynligt, at Anavex inden for en relativ kort tidshorisont, vil finde en partner for at magte opgaven - måske i år og senest i forbindelse med opstart af dette nye fase 3 forsøg.
Anavex kværner derudaf med videnskabelig velfunderede beviser og forsøg - uagtet kursudvikling og manipulation.
Casen styrkes og underbygges for hver dag - den måde Anavex agere på bekræfter kun, at man er 100 % overbevist om at skidtet virker og ikke giver uønskede og uforudsete bivirkninger. -
Rigtigt Thorkild det var en WS reaktion, hvor alle fik tæsk for et selskabs resultater. Den bølge har vi jo også redet på da det gik op
MayoMobile påpeger, at ANVS data skulle have vist meget bedre takter end AVXL pga patienternes stadie i AD - MMSE 24-25, hvor de data vi har set fra AVXL var fra patienter i senere stadier (alvorligere sygdom) MMSE 21.
Manden med det umulige navn har en anden vinkel på det issue. Han mener, at ANVS har lavet er dårligt forsøgs-setup.
AD pts med MMSE omkring 25 har meget svingende kognitive evner, som afhænger af dagen. Da placebogruppen var med 6 pts og den behandlede gruppe var på 10 pts så har det lille antal pts i begge grupper og specielt placebogruppens bevirket, at signifikans ikke blev opnået. Der er risiko for, at forsøgets "power" har været for spinkelt til at vise det sande udfald.
Med andre ord har naturlig variation, som er stor netop i den behandlede gruppe, forstyrret resultatet. Det korte forsøg har også medvirket til denne konklusion.
Placebogruppens forbedring af ADAS-COG 11 efter 25 dage understøtter påstanden.
Så ANVS er ikke dømt ude af Peter Karol (Ihub alias)
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Thorkild du behøver ikke at undskylde, der større chance for at folk ser den, ha-ha, og de kan bedømme selv.
Ja mange af de analytiske journalister ved ikke ret meget om emnet, ingen tvivl om det.Det ser ud som om at WS bedømmer alle små udviklings Alz firmaer under stor set samme fane, Biogen var stor set urørt af det dramatiske fald. De 3 små har kørt op og ned sammen over de sidste 6 måneder men dog med Anavex som efternøler.
Jeg (og mange andre) kan ikke forstå at Anavex nøler efter de andre to så meget!
Tror de ikke på Anavex og deres 2-73? Er det for godt til at værre sandt? Har selv fuld tiltro til Missling og hans "gameplan", han kører stille og roligt firmaet i position uden de store armbevægelser, intet praleri men kun stort set data and en antydning her og der. Ingen tvivl om at manden er dybt intelligent men nok ikke typen Amerikanerne falder i svime over hvilket måske er medvirkende til WS tøven? -
Hold dog op, hvor ved I meget, I dygtige skribenter.
Noget, jeg spekulerer på, når det gælder PDD trial resultaterne er:
Jeg forstår simpelthen ikke, at det er muligt i en placebogruppe med PDD overhovedet at påvise en negativ udvikling af sygdommen, som ikke bare er tilfældig. Det drejer sig jo om et forsøg på kun 14 ugers varighed. En sygdom, der udvikler sig langsomt. Min sunde fornuft siger mig, at sådan et forsøg burde vare meget længere for at data fra placebogruppen kan bruges som sammenlignigning. Men ok, resultatet er også flot, hvis man valgte at sammenligne med en gruppe, hvor der ikke skete en negativ udvikling, men blot status quo. Mon nogen kan følge mig, eller er min tankegang for uvidenskabelig? Alle vil nok påstå, at alle regler er overholdt med hensyn til evidens.
For mig er der ingen tvivl. Hvis kyndige forskere siger god for PDD trial resultaterne , så er det epokegørende...men som jeg forstår, venter vi stadig på Peer review. .Det er dette her jeg forholder mig til:
." Meanwhile, over 14 weeks Anavex's UPDRS total score was: placebo declined 3.53 points and dosed improved -10.98% for a total placebo/dosed differentiation of -14.51 points, an 18.9% improvement. A -7.1 point improvement is considered clinically meaningful. Anavex surpassed that by over double, ANVS didn't even come close."
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Det er lige præcis den slags vi skal passe på med, i et felt som er så videnskabeligt at kun de rigtigt kloge kan forstå det fuldt ud. Jeg har været med i mange bioteks, som hele vejen til fase 3 har haft de flotteste resultater. Så, i fase 3, falder det hele til jorden p.g.a noget som ingen havde set, andre overset, eller hvad man nu skal kalde det. Det er DERFOR jeg altid er sådan en brokrøv her, fordi det simpelthen ikke kan passe at "markedet" ikke har opdaget os. De andre (SAVA/ANVS) var til for kort tid siden , under et år, lige så ukendte som det påstås at Anavex er.
Nå, uagtet dette så købte jeg flere, desværre i forgårs SMILEY.Tak for de mange gode delinger i denne tråd allerede. Viden akkumulerer sig hasterigere nu, som flere er kommet med, og andre nu deltager mere aktivt rundt om på nettet, indhenter efterretninger som vi siger i forsvaret. Man kan i hvert fald ikke længere påstå at man er lokket ind i denne på et spinkelt grundlag.
VH
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Nedenstående artikel kan måske besvare nogle af dine spørgsmål ang. MDS-UPDRS skalaen og de antagelser, der ligger bag anvendelsen af skalaen mht. tidsperspektiv, populations størrelse etc. Artiklen bygger på et større langtidsstudie af sygdomsudviklingsforløbet over 5 år hos en forsøgsgruppe af nyligt diagnosticerede PD patienter.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5898442/ -
Det er fint at værre skeptisk MM.
Nu er verdens største SC bio brokrøv Adam Feuerstien på banen og sviner både ANVS og SAVA godt og grundigt til. Han har været efter Anavex før.
Kan se at de begge tanker voldsomt i pre-market, håber ikke at vi ser et andet blodbad i dag i AVXL
Alzheimer's scientists critique Cassava Sciences' study results — overblown, inappropriate, uninterpretable
Scientists said the cognitive benefit claim was exaggerated and not supported by the design of the clinical trial.
STAT (www.statnews.com)
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I-Mab : FDA Oks IND To Initiate Phase 1 Study For Protollin For Treatment Of Alzheimer's Disease
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