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VIVORYON THERAPEUTICS N.V. NL00150002Q7

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Probiodrug - PQ912

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  1. forum rang 10 DeZwarteRidder 31 juli 2023 08:15
    In July 2020, the Phase 2a/b VIVIAD study began to enroll 259 early stage Alzheimer’s patients in Denmark, Germany, and The Netherlands. A 24-week dose finding phase is testing 300 or 600 mg twice daily versus placebo, followed by up to 96 weeks treatment at the highest safe dose. The primary endpoints are safety, and efficacy on working memory and attention. Secondary endpoints include long-term safety and effects on brain activity, cognition, and daily functioning. The trial is also collecting exploratory data on the Winterlight speech-based cognitive assessment, EEG, and blood biomarkers. For more details, see the published protocol (Vijverberg et al., 2021).

    In November 2021, Vivoryon began another Phase 2a/b trial, this time in the U.S., and in collaboration with the U.S. National Institutes on Aging and the Alzheimer’s Disease Cooperative Study. The VIVA-MIND study is enrolling 414 participants with biomarker-confirmed early AD and MMSE scores between 20 and 30. The initial part of this safety and efficacy trial will titrate 180 patients in three groups to target doses of 150 mg, 300 mg, or 600 mg twice a day for at least 24 weeks, or placebo. Primary outcomes are safety, plasma levels, ADNI cognitive battery composite scores, and quantitative EEG. Based on the results, investigators will calculate target occupancy in CNS, and continue dosing these and additional participants at a level aiming for 50 percent occupancy for 72 weeks, or placebo. The primary efficacy outcome is change in CDR-Sum of Boxes from baseline to 72 weeks; secondary outcomes include the cognitive function composite CFC2 score. Study completion is expected in November 2023.

    In December 2021, the U.S. FDA granted Fast Track status to varoglutamstat.

    In June 2022, the company announced completion of the dose-finding phase of VIVIAD. Based on data from 181 patients, an independent safety monitoring board selected the highest dose tested, 600 mg twice daily, for the rest of the study (press release). Trial results are expected in the second half of 2023.
  2. forum rang 10 DeZwarteRidder 3 oktober 2023 09:56
    Het essentiele pathway om de ziekte te bestrijden blijft wazig.Nu heeft prof De Strooper een nieuw target ontdekt.Goed resultaat bij ....muizen

    Belgische wetenschappers doen belangrijke ontdekking in onderzoek naar Alzheimer: “Cruciale stap vooruit”

    Een onderzoeksteam van VIB-KU Leuven heeft ontdekt hoe zenuwcellen afsterven en kan het probleem zelfs voorkomen. Dat is een belangrijke stap naar de mogelijke behandeling van de ziekte van Alzheimer. De bevindingen van Doctor Sriram Balusu en professor Bart De Strooper, die ook verbonden is aan het UK Dementia Research Institute, zijn gepubliceerd in het wetenschappelijk tijdschrift Science.

    Alzheimer wordt wellicht onder andere veroorzaakt door de opeenhoping van ‘amyloïde’, een soort eiwit, tussen de zenuwcellen in de hersenen. Eerdere experimenten op muizen gaven nooit duidelijke antwoorden over hoe de ziekte juist te werk ging. Dat kwam omdat muizen beter bestand zijn tegen die zogenaamde ‘amyloïde pathologie’, zo blijkt. Wetenschappers botsten dan ook op de limieten van de onderzoeken met muizen, die bepaalde kenmerken van de ziekte niet natuurgetrouw kunnen nabootsen

    De onderzoekers hebben nu een nieuw model ontwikkeld, waarbij gezonde zenuwcellen van mensen en muizen in het brein van Alzheimer-muismodellen - lees: muizen waarin het ziektepatroon van Alzheimer wordt nagebootst - worden ingebracht. Dat nieuwe model leidde wél tot belangrijke inzichten. Zo werd een geprogrammeerde vorm van celdood, die bekend staat als necroptose, geactiveerd. Dat leidde tot de dood van neuronen.

    De onderzoekers zagen dat de aanwezigheid van een bepaalde molecule - genaamd ‘MEG3' - sterk verhoogd was in menselijke neuronen, net zoals bij Alzheimerpatiënten. De aanwezigheid van MEG3 alleen al zorgde ervoor dat de menselijke neuronen in een labsetting afstierven.

    Bovendien slaagde het onderzoeksteam erin het afsterven van neuronen te voorkomen, wat nieuwe mogelijkheden biedt voor toekomstige behandelingen. Door MEG3 te verminderen - en dus necroptose te vermijden - zijn de onderzoekers erin geslaagd om celdood te vermijden.

    “Meer onderzoek is nodig om exact te begrijpen hoe MEG3 necroptose in gang zet, maar de ontdekking is een cruciale stap vooruit om te begrijpen hoe Alzheimer tot verlies van neuronen in de hersenen leidt”, aldus het VIB (Vlaams Instituut voor Biotechnologie). De bevindingen zijn cruciaal om de ziekte te begrijpen en een behandeling te ontwerpen. Een proces dat mogelijk nog jaren in beslag zal nemen.
  3. forum rang 10 DeZwarteRidder 19 oktober 2023 15:32
    Diede schreef op 19 oktober 2023 15:27:

    Coverage Initiation: Vivoryon: SELL - 1 €
    Another swing and a miss in AD? Initiating with a SELL ahead of the phase 2b readout
    During 2023, the amyloid hypothesis was clearly validated with the full approval of lecanemab. Vivoryon's varoglutamstat, which inhibits amyloid plaque formation but doesn't clear existing one, showed limited to no efficacy in a short phase 2a study with significant non-adherence. While the drug is under evaluation in two phase 2 trials (VIVA-MIND in the US and VIVIAD in the EU), we believe that the VIVIAD trial is likely to fail when topline results will be reported in Q1 2024. We initiate coverage with a SELL and a EUR 1 PT.

    Koers dus van €1 door een analist van Bryan Garnier
  4. forum rang 10 DeZwarteRidder 19 oktober 2023 15:36
    quote:

    DeZwarteRidder schreef op 17 februari 2021 10:48:

    [...]
    Vergeet dat maar: fase 2A was zeer slecht, dus de vooruitzichten voor Vivo zijn nog slechter.
    .
  5. forum rang 10 DeZwarteRidder 4 januari 2024 09:09
    Bayer Clears Early Hurdle With Gene Therapy for Parkinson’s
    By Tim Loh
    January 4, 2024 at 2:46 AM EST

    Bayer AG said that its gene therapy against Parkinson’s disease succeeded in an early-stage trial, allowing the German company to start with a phase-II study of the medicine in coming months.

    The therapy was well tolerated in 11 patients with no serious adverse events after 18 months, according to a statement
    Thursday.

    www.bloomberg.com/news/articles/2024-
  6. forum rang 10 DeZwarteRidder 12 februari 2024 19:17
    Improvements with simufilam

    A scheduled interim safety review in late 2023 didn’t raise any noteworthy issues with the two trials and interim data from REFOCUS-ALZ hinted that simufilam may not carry the safety risks seen with other recently Alzheimer’s medications.

    Antibody-based treatments targeting amyloid-beta can cause swelling in the brain, known as ARIA-E (amyloid-related imaging abnormalities edema). An interim analysis of MRI data from 180 patients in REFOCUS-ALZ showed none had ARIA-E after 40 weeks, about 10 months.

    The analysis noted some instances of bleeding in the brain, known as ARIA-H, but the rates were low; about 5% of patients who didn’t have bleeding when they entered the trial had new bleeding at week 40. That’s consistent with rates of brain bleeding in patients who aren’t on treatment, so it’s unlikely these bleeds are from simufilam, according to Cassava.

    Alzheimer’s disease is characterized by toxic clumps of proteins in the brain, such as amyloid-beta and tau, which may contribute to its progression. Simufilam is designed to target filamin A, a protein that forms abnormal clumps in Alzheimer’s and that’s also involved in amyloid-beta and tau clumping. By targeting filamin A, simufilam seeks to reduce brain damage and slow disease progression. It’s also thought to have anti-inflammatory effects.

    Simufilam was tested in a Phase 2 clinical trial (NCT04388254) that enrolled 216 people with mild to moderate Alzheimer’s disease. For the first part, all participants were treated with simufilam (100 mg twice daily) for a year. Topline results from the first part involving 157 patients showed nearly half saw improvements in cognition, based on the ADAS-Cog11 , which is similar to ADAS-Cog12.

    In the next part, the participants were randomly assigned to continue taking simufilam or switch to a placebo for six months. Results showed that average ADAS-Cog11 scores worsened by 0.9 points with simufilam and by 1.5 points with a placebo.

    That works out to a 38% difference favoring simufilam, though it wasn’t statistically significant, meaning it’s plausible the difference could be due to chance. Phase 2 studies, which primarily assess safety, often don’t have a large enough sample size to detect statistically meaningful results, which is why the Phase 3 trials include nearly 2,000 patients.
  7. forum rang 10 DeZwarteRidder 4 maart 2024 11:23
    Vivoryon Therapeutics N.V. Provides Update on VIVIAD Phase 2b Study of Varoglutamstat in Early Alzheimer’s Disease

    VIVIAD Phase 2b study did not meet its primary and key secondary endpoints
    Varoglutamstat was generally well tolerated with low discontinuation rates due to adverse events and no evidence of symptomatic ARIAs in the clinical setting
    VIVIAD is a comprehensive, diligently designed and high-quality study; baseline demographics in the study were highly representative of early AD patient population
    Company is conducting an in-depth analysis of the results, including analyses of additional pre-specified and exploratory endpoints
    Further update expected to be provided no later than with publication of Company’s full year 2023 financial results

    Halle (Saale) / Munich, Germany, March 4, 2024 – Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company focused on the discovery and development of small molecule medicines to modulate the activity and stability of pathologically altered proteins, today announced topline results from its Phase 2b European VIVIAD study of varoglutamstat (PQ912), an investigational oral glutaminyl cyclase (QPCT) inhibitor in development for the treatment of early Alzheimer’s disease (AD). The VIVIAD study did not meet its primary endpoint and did not show a statistically significant difference in change over time on cognition, as measured by a combined score (Z-score) of the Detection test, the Identification test and the ‘One Back’ test (attention and working memory domains) of the Cogstate neuropsychological test battery (NTB), called “Cogstate 3-item scale”. Additionally, the study did not meet key secondary endpoints measuring cognition (Cogstate Brief Battery, CBB, and complete Cogstate NTB), Instrumental Activities of Daily Living Questionnaire (A-IADL-Q) and electroencephalogram (EEG) global theta power. Varoglutamstat was generally well tolerated and showed rates similar to placebo of serious and severe treatment emergent adverse events (TEAEs), low discontinuation rates due to adverse events and no evidence of symptomatic ARIAs (amyloid-related imaging abnormalities) in the clinical setting.

    The Company is conducting an in-depth analysis of the results, including analyses of additional pre-specified exploratory endpoints (e.g. WAIS-IV coding test, executive function and episodic memory domains, Winterlight Labs speech assessment, cerebrospinal fluid (CSF) biomarkers and additional EEG analysis) and distinct patient cohorts as defined in the statistical analysis plan, including ApoE4 status, tau level, dose level and pre-treatment.

    “We are profoundly disappointed by the outcome of the VIVIAD Phase 2b study of varoglutamstat in the early AD patient population given the huge unmet need for new safe and effective oral therapies,” said Frank Weber, M.D., CEO of Vivoryon. “I would like to express our gratitude to the patients, their families and caregivers, as well as the investigators for participating in the VIVIAD study, and to our incredible team at Vivoryon for their tireless efforts. While these results are not what we had hoped for, VIVIAD is a comprehensive, diligently designed and high-quality study and we are doing all we can to fully analyze the dataset as quickly as possible to gain insights into key findings that might influence varoglutamstat clinical development and help advance the science and understanding of this devastating disease.”

    A further update is expected to be provided no later than with the publication of the Company’s full year 2023 financial results which are expected in mid to late April 2024.
  8. forum rang 10 DeZwarteRidder 4 maart 2024 12:33
    quote:

    DeZwarteRidder schreef op 19 oktober 2023 15:32:

    Diede schreef op 19 oktober 2023 15:27:

    Coverage Initiation: Vivoryon: SELL - 1 €
    Another swing and a miss in AD? Initiating with a SELL ahead of the phase 2b readout
    During 2023, the amyloid hypothesis was clearly validated with the full approval of lecanemab. Vivoryon's varoglutamstat, which inhibits amyloid plaque formation but doesn't clear existing one, showed limited to no efficacy in a short phase 2a study with significant non-adherence. While the drug is under evaluation in two phase 2 trials (VIVA-MIND in the US and VIVIAD in the EU), we believe that the VIVIAD trial is likely to fail when topline results will be reported in Q1 2024. We initiate coverage with a SELL and a EUR 1 PT.

    Koers dus van €1 door een analist van Bryan Garnier
    Het zou me niet verbazen als Bryan Garnier en Janus een bepaalde voorkennnis hebben gehad, alhoewel ze hun mening baseren op hetzelfde als ik, nl fase 2A.
  9. forum rang 4 Diegy 4 maart 2024 12:36
    in het ongunstigste scenario kan de koers nu dalen naar 1 euro, als Vivoryon besluit te stoppen met de klinische ontwikkeling van het middel.

    Tijd voor herstel en gokje nemen en straks instappen.
  10. forum rang 10 DeZwarteRidder 4 maart 2024 12:38
    quote:

    Diegy schreef op 4 maart 2024 12:36:

    in het ongunstigste scenario kan de koers nu dalen naar 1 euro, als Vivoryon besluit te stoppen met de klinische ontwikkeling van het middel.

    Tijd voor herstel en gokje nemen en straks instappen.
    Hoe kom je toch aan dit soort onzin.....???

    De koers staat nu op 50 cent.
  11. forum rang 5 kooning 4 maart 2024 12:48
    quote:

    Diegy schreef op 4 maart 2024 12:36:

    in het ongunstigste scenario kan de koers nu dalen naar 1 euro, als Vivoryon besluit te stoppen met de klinische ontwikkeling van het middel.

    Tijd voor herstel en gokje nemen en straks instappen.
    Ik dacht dat het koersverloop van Philips een fiasco was maar het kan nog altijd veel erger zie ik hier.
  12. forum rang 10 DeZwarteRidder 4 maart 2024 12:49
    quote:

    DeZwarteRidder schreef op 19 oktober 2023 15:32:

    Diede schreef op 19 oktober 2023 15:27:

    Coverage Initiation: Vivoryon: SELL - 1 €
    Another swing and a miss in AD? Initiating with a SELL ahead of the phase 2b readout
    During 2023, the amyloid hypothesis was clearly validated with the full approval of lecanemab. Vivoryon's varoglutamstat, which inhibits amyloid plaque formation but doesn't clear existing one, showed limited to no efficacy in a short phase 2a study with significant non-adherence. While the drug is under evaluation in two phase 2 trials (VIVA-MIND in the US and VIVIAD in the EU), we believe that the VIVIAD trial is likely to fail when topline results will be reported in Q1 2024. We initiate coverage with a SELL and a EUR 1 PT.

    Koers dus van €1 door een analist van Bryan Garnier
    Het peperdure VIVA-MIND programma in de USA zal onvermijdelijk op korte termijn stop gezet worden.
  13. forum rang 10 DeZwarteRidder 4 maart 2024 13:07
    quote:

    foexie schreef op 4 maart 2024 12:55:

    Toch benieuwd wie de koper is van 1.575.820 stukkies in het begin...
    Waarschijnlijk shortdekking en maak je maar geen illusies dat iemand deze waardeloze tent wil overnemen.
  14. forum rang 8 HenkdeV 4 maart 2024 13:27
    quote:

    Rowi62 schreef op 4 maart 2024 12:38:

    Diegy zit er al naast....
    Eigenlijk is dat niet vermeldenswaardig:-).
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