Anavex HISTORISKE OG BANEBRYDENDE RESULTATER I ALZHEIMER!!!
-
Det viser jo blot, at vi skal forberede os på knaster i det fremtidige forløb.
Mange teorier om hvordan Anavex skal at komme gennem skjoldet i fda. Det bliver en vanskelig opgave.
Jeg håber, at de to tidligere fda ansatte hos Anavex kan åbne nogle døre.
Fda er heldigvis på hælene mht alzheimers og deres skandaløse godkendelse af Aduhelm. Mon ikke Lecanumab ligner Aduhelm så meget, at fortiden skræmmer fda fra at lave to fejl på stribe.
Håber at Anavex kan få 50 mg armen i hus snart. Det er den der skal være sømmet, der gør, at fda ikke kan undslå sig.
Anavex bør i min optik ikke vente for længe med at indgå partnerskab. Deres tempo alene kan godt bekymre.
Siger fda flere fase 3 skal de også have partner på ellers er der mange år til at indikationen er i hus.
Et stort US pharma (partner) der sender ansøgningen til fda tror jeg ville øge odds for at det glider gennem systemet.
-
Unmet medical need delen bør virkelig skubbe fremad hos relevante myndigheder. Data kan jo ikke bare sande til hele tiden, hvis det ene eller det andet hele tiden obstruere for fremskridt!
Skidtet er tilsyneladende helt og aldeles ufarligt; Tjek ud for det. Så man kan rent faktisk tilbyde det uden at man bliver dødlige syg af det, (modsat konkurrenternes). FDA nævner selv i deres guidlines, (frit fra hukommelsen), at Unmet er et særligt fokus område fremover, og derfor vil barren også væren en anden, (læs lavere, for at få sat skub i forskningen). Spørgsmålet er ikke så meget godkendelses delen, spørgsmålet er, om fagpersoner herunder nøglepersoner rundt omkring på kloden vil anbefale deres respektive sundheds sytemer og patienterne et stof! Her taler foreløbige data for sig selv.
De efterfølgende peer reviews i de videnskablige litteratur tidsskrifter, vil formentlig gør det helt klart hvad vi taler om. Husk det allervigtigste, udover, progression af lidelsen, er bivirkningsprofilen..
-
Pharma- og biotekopdatering uge 50:
-
Anavex Nyansatte Timo Grimmer og 3 andre Podcast med CTAD.
En tyske podcast med 4 tyske professorer, heriblandt Timo Grimmer diskuterer den afsluttede CTAD konference.
Dvs. i de ca. 24 min. podcastet vare, så bruger de godt 21 min. alene på Biogen og Lecanemab. Her er de umiddelbar positiv over for resultaterne - de diskuterer dog de 2 dødsfald og nødvendigheden for monitering af patienter og måske en begrænsning til hvilke patienter, der kan få Lecanemab. Men især den ene så frem til at det kom på markedet på et tidspunkt. Der blev også diskuteret, om de forventede måske 6 mdr. Lecanemab evt. kan forlænge sygdomsforløbet, står mål med de økonomiske omkostninger og de menneskelig omkostninger ved selve behandlingsmetoden og skanninger.ENSTE andet selskab der nævnes og omtales positivt er Anavex, hvor Timo Grimmer igen fortæller, at 2-73 har en rigtig god bivirkningsprofil og at patienterne bliver mindre demente i løbet af de 48 uger - samtidig bemærkes der også, at medicinering via tabletform er at foretrække ifht. Biogens intravenøse behandling og løbende skanning af hjernen.
Det undrer mig dog, at de andre professorer ikke havde noget at sige til (læs - faldt på halen over), at patienterne modsat hos Biogen blev bedre?
Der var ikke nogen "løftet øjenbryn" over, at AD patienterne blev bedre - i stedet for blev der igen snakket om Biogen og muligheden for at få Lecanemab på markedet i Europa?
Jeg tænkte bare - MANDEN SAGDE LIGE AT PATIENTERNE BLEV BEDRE OG UDEN BIVIRKNINGER, OG I NÆSTE SÆTNING SÅ SNAKKEDE DE GUDHJÆLPENE OM AT FÅ LECANEMAB PÅ MARKEDET! - HALLO ER DER NOGEN HJEMME???Timo Grimmer er jo efterfølgende blevet ansat af Anavex (som 5. eller 6. tysker i teamet) og alt andet lige, så er det positivt, at Anavex som de eneste udover Biogen klarede at blive omtalt på denne ROCHE podcast.
Meget interessant at man lige i ROCHE regi omtaler Anavex, da de jo lige har stoppet deres fedtfjernelsesprogram i AD og nu siger at de forsat ønsker at være aktiv i Alzheimer, men nu via. en partner, som har anden forskning/platform i Alzheimer! -
Anavex-Når resultaterne , som Anavex har opnået med 2-73, er så gode som div. forskere og professorer inden for området giver udtryk for, burde Anavex så ikke gå mere aggressiv ud i diverse medier for at formidle denne viden ud til almindelige borgere ?! Organisationer som burde varetage syge borgers interesse, samt FDA,hænger øjensynligt da noget i bremsen
-
Anavex otul - forventer også at Anavex bliver mere aktive med at få budskabet ud, når de har færdigbehandlet de samlede data og gjort dem mere entydige og sværere at modargumenterer af markedet og især af dem, som har stor interesse i, at Anavex ikke får succes.
40 min. grundig gennemgang på JP Morgan den 12. Januar 2023, kan blive startskuddet til at få banket de gode resultater ind i omgivelserne.
Anavex er helt klar over, at enhver usikkerhed eller tvivl i de samlede data vil blive brugt mod dem - de skal derfor være helt skudsikre.
Som vi ser nu, tør ingen større analytiker end ikke stikke kursmål ud - ville være en fin start, hvis JP Morgan lagde for, når det nu er dem selv, der har inviteret Anavex til deres egen kongres. ( man kan kun blive inviteret med på JP Morgan)
Får vi som lovet resultaterne fra PDD OLE her lige om lidt, kan disse være med til at underbygge AD data, pga. sammenfaldet i indikationerne og virkemekanismen.En partneraftale med f.eks østriske ROCHE, ville passe rigtig fint sammen. Bare sproget og måske tilgange/mentaliteten ville de 5-6 tysker i ledelsen hos Anavex, måske kunne få et bedre konstruktivt samarbejde med en østriske ledelse, end med f.eks et US selskab.
Dette udover, at ROCHE netop lige mangler en partner med en ny Alzheimer platform, da de som tidligere skrevet, jo har skrottet deres egen fedtfjernelsestilgang.Pga. skattemæssig forhold, behøver der for min skyld ikke at komme alt for meget positivt kursmæssig før den 31. december - tror dog "desværre" ikke, at vi kan undgå dette, da Anavex jo har lovet flere milepæle i indeværende år.
-
Anavex og Blarcamesine nævnt i "Nature"
Biogens Lecanumab sætter der spørgsmålstegn ved ...
Det rette perspektiv kommer måske frem over tid.
-
Anavex "Nature" er åbenbart ikke i lommen på BP.
Godt fundet Solsen:)
Alzheimer's drugs
In early January, US regulators will announce whether a drug that slowed down the rate of cognitive decline in a robust clinical trial1 can become available to people with Alzheimer's disease. Developed by the pharmaceutical company Eisai and the biotechnology firm Biogen, lecanemab is a monoclonal antibody that clears amyloid-β protein that builds up in the brain. The clinical trial included 1,795 people with early-stage Alzheimer's and showed that lecanemab slowed mental decline by 27% compared with a placebo. However, some scientists think this is only a modest benefit and others are concerned about the safety of the drug.Another Alzheimer's drug, called blarcamesine - developed by Anavex Life Sciences in New York City - will continue to make its way through clinical trials. Blarcamesine activates a protein that improves the stability of neurons and their ability to connect with each other.
Anavex har tidligere været omtalt positiv i "Nature", vedr. Fragile X:
-
Anavex Et tætpakket program i resten af 2022.
Dette når de næppe - det primære er, at de bruger al krudtet på at få analyseret og præsenteret hele datapakken fra AD fase 2/3.
Skulle vi nå at få gode PDD OLE data og måske at RETT er afsluttet, så må resten godt vente til 2023 - iflg. IR burde vi få min. PDD OLE.
8 handelsdage tilbage og spørgsmålet er hvor aktive er man mellem jul og nytår - kun den 26. dec. er der lukket og fredage er sjælden brugt til nyheder - så meget taler for nyheder en af de næste 3 dage.
https://www.nasdaqtrader.com/Trader.aspx?id=Calendar> Data of 48-week OLE PDD Phase 2 study - expected by end 2022
> EXCELLENCE completion: Potentially pivotal Phase 2/3 pediatric RTT clinical trial - expected by end 2022
> Initiation of ANAVEX
2-73 imaging-focused Parkinson's disease clinical trial - expected 2022
> Initiation of potentially pivotal ANAVEX2-73 Phase 2/3 Fragile X clinical trial - expected 2022
> Initiation of potentially pivotal ANAVEX2-73 Phase 2/3 clinical trial for the treatment of a new, rare disease indication - expected 2022
> Initiation of ANAVEX3-71 Phase 2 clinical trial for FTD, schizophrenias and Alzheimer's disease - expected 2022 -
Anavex...En anmodning der er helt i skoven.
Alzheimer’s Association Calls on CMS to Reverse Its Decision to Severely Limit Access to FDA-Approve
Alzheimer’s Association Calls on CMS to Reverse Its Decision to Severely Limit Access to FDA-Approved Alzheimer’s Disease Treatments
Alzheimer’s Association (www.alz.org)
Elendige monoklonal tilgang til amylin fjernelse er ikke til patienternes beste. Money talks af værste skuffe.
Come on Anavex!
-
Anavex...Ingen tvivl om at der er megen fokus på AD mv
Congress Prioritizes Addressing Alzheimer’s and Dementia
Key provisions of the ENACT Act, strengthened FDA accelerated approval pathway, a $226 million increase for research and $33 million to fund Alzheimer’s public health in FY23 budget bill.
Alzheimer’s Association (www.alz.org)
Come on Anavex
-
-
Anavex Ja ringene spreder sig - men meget langsomt.
Forbes:
One company using a technology-driven approach to drug discovery is Anavex Life Sciences. Anavex is developing a drug to help Alzheimer's patients. The company used a precision medicine approach and recently announced positive results in its Phase 2B/3 clinical trial. The company leveraged Ariana Pharma's AI technology to illustrate the promising results of its drug.Når sponsoratet fra BP bare er stort nok til The Alzheimer's Association, så bliver de nok ved med at sige, at jorden er flad (fedtfjernelsestilgangen) - selvom Anavex med deres innovative tilgang og resultater har vist, at jorden faktisk er rund.
Håber mere og mere på, at Anavex kører udenom FDA og US og først kommer på markedet i nogle af de lande, hvor de har kørt deres vigtigste forsøg.
-
Anavex Meget positive World Financial Review!
Fremtidens behandling af demens!
Dejligt at stadig flere er begyndt at få øjnene op for den innovative videnskab der ligger til grund for Anavex`s platform.
På et tidspunkt skal aktiekursen nok afspejle dette - en partneraftale eller en markedsgodkendelse/myndighedsudmelding i et eller andet, et eller andet sted i verden, vil få tingene til at eksploderer!!How Digital Innovation Is Changing Life Sciences and the Way We Treat Dementia
Dementia develops when nerve cells in the brain, the spinal cord, and its connecting tissues are damaged or lost. Nerve cell damage happens most often because of underlying diseases, such as Parkinson's or Alzheimer's. Despite scientific advances, once nerve cells have been damaged, they cannot be regenerated.
With multiple functions in protecting nerve cells in the brain and the spinal cord, the sigma-1 receptor has emerged as one of the main targets in treating diseases like dementia. Those with dementia have been found to have a much lower volume of sigma-1 receptors. ANAVEX
2-73 binds to this receptor and increases its activity.
Research and early clinical trials have been supported by the Michael J. Fox Foundation for Parkinson's Research. Since then, the drug successfully completed several stage-two trials that have shown that it can improve common symptoms of dementia.When envisioning the future of dementia treatment, trials of ANAVEX
2-73 suggest that society may be close to being able to effectively treat dementia conditions. Trials of this drug related to Parkinson's disease dementia showed improvements in movement- and non-movement-related symptoms of the disease.6 Scientists linked the improvement in symptoms to higher activity levels in the patients' sigma-1 receptors. Blood tests on trial participants also showed that the drug improved the function of genes that have been impaired in patients with Parkinson's, Alzheimer's, and other dementias.Scientists are on the brink of offering simple, yet powerful treatments to improve disorders of the brain and spinal cord. Anavex Life Sciences is an industry-leading biotechnology company that is dedicated to finding a successful treatment for conditions that impact the brain and spinal cord.
-
Anavex. Super positiv Seeking Alpha sammenfatning.
Grundig gennemgang af de foreløbige data fra Anavex og sammenlignet med Biogens resultater.
2-73 er bedre på alle parameter!Summary
The Phase 2b/3 trial of Anavex's Blarcamesine demonstrates major, statistically significant effects in slowing Alzheimer's Disease.
The drug slowed cognitive decline by about 45% over 48 weeks on the ADAS-Cog test, a measure of cognitive ability. It appears more effective than Biogen's Lecanemab.
A number of patients on the drug demonstrated cognitive/behavioral IMPROVEMENT (rather than slowing of decline); the initial readout of results indicate some showed extreme improvement (a super-response).
The patients in Anavex's Blarcamesine trial were substantially more cognitively impaired than those in Biogen's Lecanemab trial.
Dementia and Occupational Therapy - Home caregiver and senior adult woman
FredFroese/E+ via Getty ImagesAnavex (NASDAQ:AVXL) has just completed a Phase 2b/3 trial of its new Alzheimer's drug, Blarcamesine, and the company reported initial results on December 1. It will report the full set of results and data before meeting with the FDA about what to do next.
In November, Biogen (BIIB) published its full set of results for its new Alzheimer's drug, Lecanemab.
Analyzing both sets of results, it seems apparent to me that dementia patients will prefer Anavex's Blarcamesine, based on both performance and side effects (see below).
[In separate 48-week tests, Blarcamesine trounces the currently available Alzheimer's treatment, Donepezil, in performance]
In Blarcamesine's 48 week trial, patients on the drug benefited from a 45% reduction in cognitive decline (versus placebo) based on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) scores of patients. The ADAS is a test of thinking ability and memory. The worse your brain is working, the higher you score on the test. Those who took the placebo got worse by 4.11 points and those who took Blarcamesine got worse by only 2.26 points over 48 weeks.
The patients in the Anavex Phase 2b/3 trial started the trial with an ADAS-Cog of around 29; this is a serious level of cognitive impairment, and this group typically gets worse by about 4.5 points in a year's time. So, the 2.26 point decline among those treated with Blarcamesine represents about a halving of decline compared to the untreated.
Some patients taking Blarcamesine in their Phase 3 trial actually improved, rather than reducing decline. And those individuals who did improve, according to Anavex, improved by a whopping 4.06 points on average on their ADAS-Cog scores! This is an absolute improvement over their individual baseline measurements.
A 4-point improvement versus a 4-point decline? The 8-point difference can mean the difference between being normal and being diseased. Stunning.
Those taking Blarcamesine were divided into two equal groups of 169 patients. One group took 30 mg of Blarcamesine each morning and the other group took 50 mg each morning. In the previous trial, (Phase 2), the drug was more effective at the 50 mg dose than at the 30 mg dose. The latest trial was a Phase 2b/3 trial and may lead to FDA approval of Blarcamesine.
The results seem to indicate that those taking the 50 mg dose of Blarcamesine may have benefited much more than those who took the 30 mg dose each morning.
Blarcamesine also reduced decline in overall impairment by 27% as measured by the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB), a more global measure of cognition and behavior. This is very impressive, however, it is not as impressive as Blarcamesine's performance regarding the ADAS-Cog, a test that is purely focused on cognition and memory.
Perhaps Blarcamesine does not improve everyday functioning as much as it improves brain function. The Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS-ADL) measures performance of patients' daily living habits, based on caregiver interviews regarding the previous four weeks. Anavex did not report the mean change in ADCS-ADL.
Anavex only stated that those taking Blarcamesine were 167% more likely to improve their ADCS-ADL score by at least 3.5 points than were those on placebo pills. This means that if 12% of the placebo group improved their scores by at least 3.5 points, then about 32% of those taking Blarcamesine improved their scores by a very practically relevant 3.5 points or more on a 78-point scale. Of course, without any medication, patients are expected to decline in their performance.
Nevertheless, the lack of complete information seems to indicate that the overall ADCS-ADL numbers were not better than those of Biogen's Lecanemab, to which Anavex actively compared its drug in its most recent public presentation.
Comparing Blarcamesineemine And Lecanemab In Treating Alzheimer's Disease
While Anavex (AVXL) produced a partial readout of results for its daily pill, Blarcamesine, on December 1, Biogen (BIIB) produced a full readout of Phase 3 trials for its vaunted new biweekly intravenous treatment, Lecanemab, in November.The results for Biogen's Lecanemab are encouraging despite some people suffering terrible side effects. But if Lecanemab's results were encouraging, then Blarcamesine's results are downright exciting.
Regarding the ADAS-Cog Scores. Cognitive decline was measured by the difference in change in the ADAS-Cog score versus change in ADAS-Cog score in the placebo arm over 48 weeks. In both studies, the placebo arm deteriorated in cognition at a faster rate than the treatment arm. Blarcamesine reduced deterioration by 40% more than Lecanemab at 48 weeks.
Furthermore, the Blarcamesine patients started off their drug trial with a good deal more cognitive dysfunction than the Lecanemab patients. The average ADAS-Cog scores of the Lecanemab trial was 24.45. The average ADAS-Cog scores of the people being administered Blarcamesine was 28.75. That's a 4.3 point difference, a very substantial difference in starting points.
Blarcamesine is 40% more effective than Lecanemab at 48 weeks, and on patients who are significantly more cognitively impaired. To be fair Lecanemab's trial continued for another 7 months and continued to slow impairment. Blarcamesine's trial ended at 48 weeks, and patients have the option to continue treatment in another study; will Blarcamesine continue to hold its 40% lead over Lecanemab? It is unclear, but it seems one's first year of Alzheimer's treatment should be on Blarcamesine.
Regarding the CDR-SB. The Blarcamesine patients were suffering from greater global impairment than the Lecanemab patients, as measured by the CDR-SB. At BASELINE (at the start of each study) the Blarcamesine patients had an average CDR-SB score of 3.81 versus Lecanemab's 3.17, representing significantly more impairment among the Blarcamesine group.
The Blarcamesine patients at baseline were suffering from Very Mild Dementia or Mild Dementia, while patients in the Lecanemab trial were suffering from Very Mild Dementia, Mild Dementia, but also "Questionable Impairment" (very little impairment, if any). See this link for a full discussion.
In this context, it is quite remarkable that the Blarcamesine patients reduced their cognitive decline by 27% over 48 weeks, while Lecanemab produced a similar 27% reduction in cognitive decline, except it took Lecanemab over 78 weeks (18 months). What would Blarcamesine accomplish given another 7 months?
Anavex hints that the drug would continue to reduce decline such that by 78 weeks, Blarcamesine would have a healthy lead over Lecanemab. The suggested logic is, if Blarcamesine at 11 months is equal to Lecanemab at 18 months, then given an equal amount of time to work, Blarcamesine should stretch to at least a 50% lead over Lecanemab.
Regarding ADCS-ADL. It is on the ADCS-MCI-ADL that Biogen's Lecanemab produced its best results. Those who took the drug saw a 37% reduction of decline compared to placebo over the course of over 78 weeks. Some strange numbers hang over the results. Men reduced their decline by almost 3x what women did. And Hispanics reduced their decline by about 3x-8x what non-Hispanics did (3x in the US and 8x outside of the US). Hispanics made up a major portion of their trial population, while Blacks did not.
In their initial readout, Anavex did not present much data on its ADCS-ADL results, one of their main endpoints. The company will release the full data set, including all the ADCS numbers before they submit a paper for publication in a peer-reviewed journal and before they meet with the FDA to discuss approval.
Perhaps the results of the ADCS were disappointing. This possibility is contradicted by a statistic the company did report: those who took Blarcamesine were 167% more likely to improve their ADCS-ADL score by 3.5 points than placebo.
Alzheimer's patients, especially those as deteriorated as the ones in the Blarcamesine trial were, are expected to get worse over the course of 48 weeks unless they are given a placebo or medication. In this case, I would expect very reasonably that maybe 12% of the placebo group improved 3.5 points on a measure that has far more to do with morale and mood than the ADAS-Cog. For instance, one question asks the caregiver how much help does the patient need in eating? The more optimistic one feels, the more likely one will refuse help and find a way to eat even if it requires a great deal of effort. Placebos provide optimism.
So, if 12% of the placebo arm improved by 3.5 points, then more than 32% of those who took Blarcamesine improved by 3.5 points or more. If that is the case, then a major portion performed magnificently with the help of Blarcamesine.
What about the other two-thirds? The ADCS is a questionnaire taken by the caregiver regarding the previous four weeks of helping the patient. In a trial that lasted only 48 weeks and for a psychotropic medication that may take numerous weeks to ramp up, the 44th week may not have been so pretty as the 47th week. Plus the caregiver may have their own biases. I would consider the ADCS scores to be the least reliable of the three measures that Anavex used as endpoints.
Regarding Side Effects. Blarcamesine trounces Lecanemab. About 3% of those who took Biogen's drug suffered from symptomatic brain hemorrhaging. Many more suffered asymptomatic brain hemorrhaging as well as noticeable brain swelling. Such symptoms may not prevent millions of desperate people from taking Biogen's Lecanemab, if it is approved and if there is no other alternative.
But 3% of one million is 30,000 people who must get treated or examined for brain hemorrhaging at an advanced age.
Further, two people in Biogen's Lecanemab study died under circumstances that suggested brain hemorrhaging contributed to their deaths. The doctor who performed one of the autopsies had this to say, as reported by Fierce Biotech.
Rudolph Castellani, a Northwestern University Medical Center neuropathologist who autopsied the body at the request of the patient's husband, is quoted in Science as being unequivocal about the role lecanemab played in the death. Talking in a personal capacity, Castellani is reported as saying: "There's zero doubt in my mind that this is a treatment-caused illness and death. If the patient hadn't been on lecanemab she would be alive today."
Having one patient die due to brain hemorrhaging, a known side effect of Lecanemab, represents a tiny fraction of the patient population.
Biogen reports that 859 patients took Lecanemab. If only 1 patient dies for every 900 patients, and 3 million people desperate for a cure decide to take Lecanemab, then 3,333 people will die from this Lecanemab side effect. While millions will certainly find the risk acceptable, it does seem like an avoidable catastrophe (avoided by taking the safer drug).
Because of these brain damage risks, those taking Lecanemab must get MRI tests done on their brains on a regular basis to check on the common side effect of brain swelling (a 600% increase in risk of brain swelling compared to placebo).
And finally, Lecanemab is taken through an IV infusion into a vein, every two weeks at the doctor's office. This can result in injection problems. And a lot of hassle and expense.
Blarcamesine is a once-daily pill, and patients in the trial were required to take the pill in the morning. Some of the patients complained about dizziness and confusion, and a small fraction of patients dropped out due to these side effects. Anavex suggested that some of these symptoms may be alleviated by taking the drug at night rather than in the morning. Interestingly the complaint of "falling" was reduced among those taking the Anavex drug. No drug-related deaths were reported.
Allowing Patients To Use Blarcamesine Rather Than Lecanemab May Save Thousands Of Lives.
Some Patients Improved Rather Than Reduced Decline
Biogen reported no actual patients improving after using Lecanemab or using placebo. This does not mean that there were no patients in their trial who improved. I would expect at least 10% of their patients under placebo to have improved. The placebo effect is powerful and it is the most consistent effect in all drug trials. The sense of optimism one feels under placebo can be especially powerful in helping patients being measured in their behavior and to a lesser degree their cognition.Improvement on any measure was not an endpoint that Biogen claimed for its trial.
Anavex claims that substantial, clinically relevant improvement is one of its goals. And its measure for this is the probability that one will actually improve rather than slow decline while using its drug, Blarcamesine, versus placebo. In this measure, which some people find little use for, Anavex succeeded spectacularly.
On the ADAS-Cog, Blarcamesine-takers were 85% more likely to improve their scores by at least .5 points, a level of improvement that Anavex claims is noticeable in one's quality of life. Based on this statistic I am happy to buy some Blarcamesine for my mother, who has Alzheimer's, and myself too, when I show signs.
On the ADCS-ADL, the measure of everyday habits, Blarcamesine-takers were 167% more likely to have improved by at least 3.5 points, indeed a substantial improvement. And of course, this makes me want to utilize the drug even more. I like those odds.
But, for a traditional drug trial, these numbers are not what many scientists want to see. They are more interested in numbers such as the mean change in ADAS-Cog relative to placebo, as presented and discussed above.
30 mg Vs. 50 mg Of Blarcamesine And Super-Responders
FOR THOSE ON BLARCAMESINE WHO DID IMPROVE their ADAS-Cog scores, the average improvement was an amazing 4.06 points. This was weird. The overall average change among those taking Blarcasemine was a deterioration by over 2 points. How can these two numbers be part of the same drug trial?If we assume that the distribution of changes in ADAS scores is normal -- a normal distribution -- then I would expect the average improvement to be closer to 1 point. There should be a lot of 1-point improvements, fewer 2 or 3 point improvements, and even fewer 4 or 5 point improvements.
One possibility is that it is a very flat curve on the side that represents improvement and a very sharp drop-off on the other side of the bell curve. The tail on the side of improvement must be very long and would likely have to extend beyond 10.
Of course, if one improves one's ADAS-Cog from 30 to 20 over the course of 48 weeks, this would likely be called a miracle.
Another possibility is that there are two clusters of those who improved. Perhaps the people who took 30 mg improved by 1 point on average. And perhaps among those who took the 50 mg dose, there were also some who improved by only one point or so, but rather than there being a "tail" on the curve, there is another cluster of improvers who improved by an average of 7. If you want an average of 4, after all, and you have a cluster of 1's, you have to have an equivalent cluster of 7's, or a smaller cluster of say, 10's, or three times as many 5's than 1's. The last case does not seem to gibe with the overall average.
This hypothetical group who improved by an average of 7 points or more may be called "super-responders." I am not validating any unverified blogs that claim researchers have reported "super-responders". I am ONLY looking at the data, and I am trying to understand how the average person who improved did so by over 4 points. The simplest explanation is the emergence of super-responders, who likely benefit far more than others due to genetic factors or because of the nature of their disease.
Of course, I am willing to go to many lengths to find out if my mother or I are super-responders. I want access to the drug, and so do many others.
Thoughts On Why The Stock Tanked
In my opinion, Anavex stock has not zoomed up based on the initial results of the Phase 2b/3 trial because:-
Anavex did not provide the mean change in ADCS-ADL scores versus placebo; they only provided the statistic that those who took Blarcamesine were 167% more likely to improve their scores by 3.5 points. There may be some level of poor performance on this endpoint.
-
Immediately after Anavex published their data on December 1, many powerful "reporters" and "influencers" began claiming that Anavex's numbers were incorrect. Some of these influencers had a reputation for "bashing" companies. The chief accusation was that Anavex purposefully, or accidentally, made a simple subtraction error and the actual change in mean ADAS-Cog scores was less than the 45% reported.
The next day, CEO Christopher Missling explained how the ADAS-Cog calculations were made in an Investors Business Daily article. The explanation was expanded upon in a public presentation on December 5. One subtracts the final ADAS-Cog score from the original score for each individual; and then one finds the average of these individual differences. If there was no final measurement, then the individual difference was omitted. Makes sense, right?
Writers continued to claim that Anavex calculated their numbers wrongly. Interestingly, none of these meticulous data-combers, as they might characterize themselves, said anything about the glaring contradictions in Biogen's Lecanemab presentation. For instance, on two separate lines, both on page 34 of their presentation, Biogen stated that use of Lecanemab accelerated the cognitive decline of Hispanic and Black patients by 222% and 221%, respectively, compared to placebo. On those same respective lines, Biogen claimed that these apparently terrible results represented a slowing of cognitive decline relative to placebo.
- Biogen's Lecanemab's successful Phase 3 trial was covered by all major mass media outlets, both upon presentation of their initial results as well as the final presentation of results. Famed financial analyst Jim Cramer has spoken extensively on both of Biogen's Alzheimer's drugs, sometimes being quite critical.
Anavex's Blarcamesine's successful Phase 3 trial was covered only by financial opinion and news outlets, and no other media outlets.
The Alzheimer's Association has 13 press releases regarding Lecanemab documented on its website. It has zero regarding Blarcamesine. As I continue to communicate with the Alzheimer's Association, I have not yet met anyone who has heard of Blarcamesine, nor anyone who has called me back regarding my questions about the drug.
Some of the influencers who speak on Anavex have been critical or accusatory with little evidence. "@InvestorsClubSpringer" is one live-streaming investing "guru" who favors Cassava Sciences over Anavex; he produced a number of videos on AVXL, but the most amusing one is "LLY and AVXL Sabotage SAVA? Five Biotechs Set To Double, and One Going 179x." Watch the first three minutes to get the gist of the conspiracy theories he hints at; you decide if he has presented any real evidence.
The Financial Potential
Worldwide 55 million people suffer from Alzheimer's disease. I believe that this number is an underestimate, as many people who suffer from Alzheimer's are never diagnosed.If one out of eleven afflicted people, or 5 million people, pay for Blarcamesine, and they each pay $4000 per year, mostly in the high and middle-income nations, then that represents $20 billion per year in revenue.
If Blarcamesine is approved for the entire spectrum of cognitive impairment, then the numbers will increase. If Blarcamesine is prescribed as a preventative measure for those at high risk of Alzheimer's, that's an additional source of revenue.
When Biogen presented its initial results for its Phase 3 Lecanemab trail, the company's market cap increased by about $14 billion, the share price increasing from about 200 to 300 dollars. The stock has dribbled downward since around the time of the Anavex announcement; this may or may not be coincidental.
Health insurance companies will prefer Anavex's Blarcamesine over Biogen's Lecanemab, as widespread use of the Biogen drug may result in millions of additional MRIs each year, in order to monitor for brain hemorrhaging caused by Lecanemab. Also, Lecanemab may cause thousands of deaths and possible lawsuits.
Blarcamesine seems to be a good deal more effective than Lecanemab in slowing cognitive decline.
Blarcamesine also seems likely much better at actually improving cognition.
Blarcamesine certainly presents far better, non-lethal side effects.
My being at high risk of dementia, I would certainly prefer trying Blarcamesine for a couple of years before even considering Lecanemab.
Financial Risks
Some have said that Anavex has presented information that is not correct. If this is the case, and the drug actually does not work for Alzheimer's, then the value of the company may be limited to the 100s of millions, assuming that it will be approved for the Rett syndrome treatments (already-successful Phase 3 trials). Note that Anavex, via a Phase 2 trial, has demonstrated promise in treating Parkinson's Disease as well. A Fragile X treatment (orphan drug designation) and other treatments are further upstream.If the ADCS-ADL scores turn out to be disappointing, but the ADAS-Cog and CDR-SB scores remain what they have been reported, the FDA will still approve Blarcamesine for Alzheimer's treatment, in my opinion. In this scenario, Blarcamesine would be approved on the grounds that it slows cognitive decline even if it does nothing to improve the eating or shopping habits of patients. In fact, it would be approved on the basis that it slows cognitive decline better than any known drug as of yet.
If Anavex needs to be subsumed by a Big Pharma corporation such as Eli Lilly (LLY), then Anavex may be bought out at a lower stock price than it would have otherwise reached if it were to market Blarcamesine on its own. Lilly could easily front $14 Billion dollars (based on the Biogen numbers above), and profit handsomely. Lilly is worth $342 Billion as of this writing.
Price Targets
Cantor Fitzgerald has a price target of $11 on AVXL stock, and Jones Trading believes AVXL will reach $80. I would prefer not to opine on a price target for Anavex stock. It is such a binary situation.Given that, I believe that if the FDA rejects Anavex's Alzheimer's application, and if it only has the other ongoing drug trials to fall back on, the stock is worth 9 dollars a share, until one of its drugs is approved by the FDA. The Rett Syndrome application is worth in the 100s of millions and a Parkinson's approval is worth in the billions. The stock trades in the mid-8s as of this writing.
If Blarcamesine is approved for Alzheimer's, I believe the stock is worth over $180 per share based on the $14 billion estimate, and not including the value of the treatments for Rett, Parkinson's, Fragile X, and others. Please investigate the exciting Phase 2 placebo-controlled trial of Anavex's Parkinson's treatment, which may be worth billions, in my opinion.
The remaining data for the Blarcamesine drug trial might be made available during Anavex's presentation at The J.P. Morgan Healthcare Conference on January 12, 2023. The Anavex session starts at 8:15 a.m., Pacific Time.
-
-
Fantastisk med en seriøs artikkel, som både er velargumenteret og velovervejet - endda nogle ret skarpe bud på den manipulation der er foregået. Det er tankevækkende at The Alzheimer's Association ikke reagerer på "normalt" på de henvendelser som The Political Economist (artikel-forfatteren) foretager. En skam at denne skribent kun har 391 followers - desværre alt for lidt til at batte noget...
-
God morgen fra Thailand, har været på en længere rejse i nabo landene og havde ingen mulighed for at kommentere men jeg har skam stadig alle mine aktier og er meget begejstret over resultatet i AD2/3 forsøget.
The Alzheimer's Association er betalt af de store bio selskaber så jeg er overhovet ikke overrasket over deres manglende dækning af Anavex's data, den forening dækker overhovet ikke patienternes interesse, men er mere et taleroer for de tunge bio selskaber, meget Amerikansk.
Også når man tænker på hvor mange milliarder af $ som der bliver brugt hvert år til pleje af AD patienter så er der ingen tvivl om at der er store kræfter på spil der helst så at 2-73 aldrig kommer på market.En BP partner er som før nævnt vejen frem.
Her er linket til den udemaerkede S.A. artikel:
God jul til alle her på tråden.
-
Jeg tænker at vi som Anavex interesse gruppe jo har vores demokratiske stemme. Derfor vil jeg opfordre alle der læser denne tråd til at lave en basic (gratis) profil på SeekingAlpha og trykke follow på denne artikels skribent. Måske også opfordre venner og familie til at gøre det samme. Spreed the good news
https://seekingalpha.com/subscriptions
Hello! It looks like you're interested in this conversation, but you don't have an account yet.
Getting fed up of having to scroll through the same posts each visit? When you register for an account, you'll always come back to exactly where you were before, and choose to be notified of new replies (either via email, or push notification). You'll also be able to save bookmarks and upvote posts to show your appreciation to other community members.
With your input, this post could be even better 💗
Tilmeld Log ind