Gantenerumab

ADDF STATEMENT ON GANTENERUMAB DATA PRESENTED AT CTAD

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Thursday, December 1, 2022
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SAN FRANCISCO, Nov. 30, 2022 /PRNewswire/ -- The phase 3 trial results for lecanemab and gantenerumab presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference demonstrate why optimal treatment of Alzheimer's will require drugs that do more than clear amyloid plaques. While lecanemab had an effect on slowing cognitive decline and removing amyloid plaques in the brain, gantenerumab had neither effect according to data reported today by drugmaker Roche.

Key Points: 
  • While lecanemab had an effect on slowing cognitive decline and removing amyloid plaques in the brain, gantenerumab had neither effect according to data reported today by drugmaker Roche.
  • "This is a historic CTAD conference, reflecting tremendous progress in Alzheimer's research and drug development.
  • We have seen a lot of encouraging news, including the lecanemab results and clinical trial data from other classes of drugs that demonstrate the diversity of the pipeline," said Dr. Howard Fillit, Co-Founder and Chief Science Officer at the ADDF.
  • Through the generosity of its donors, the ADDF has awarded more than $209 million to fund over 690 Alzheimer's drug discovery programs, biomarker programs and clinical trials in 19 countries.

EQS-News: MorphoSys’ Licensing Partner Roche Provides Update on Phase 3 GRADUATE Program for Gantenerumab in Early Alzheimer’s Disease

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Sunday, November 27, 2022
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MorphoSys AG (FSE: MOR; NASDAQ: MOR) announced today that its licensing partner Roche (SIX: RO, ROG; OTCQX: RHHBY) provided an update on the GRADUATE I and II studies evaluating gantenerumab in people with early Alzheimers disease (AD).

Key Points: 
  • MorphoSys AG (FSE: MOR; NASDAQ: MOR) announced today that its licensing partner Roche (SIX: RO, ROG; OTCQX: RHHBY) provided an update on the GRADUATE I and II studies evaluating gantenerumab in people with early Alzheimers disease (AD).
  • The level of beta-amyloid removal, the protein that builds up to make plaques in the brains of people with Alzheimer's disease, was lower than expected.
  • The GRADUATE Phase 3 program evaluated the safety and efficacy of gantenerumab in people with mild cognitive impairment (MCI) due to Alzheimers and mild Alzheimers dementia over 27 months.
  • We are grateful to Roche, our long-standing partner, for their work on the GRADUATE program and their commitment to the Alzheimers community.

Genentech Provides Update on Phase III GRADUATE Program Evaluating Gantenerumab in Early Alzheimer’s Disease

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Thursday, November 24, 2022
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced results from the Phase III GRADUATE I and II studies evaluating gantenerumab in people with mild cognitive impairment (MCI) due to Alzheimers and mild Alzheimers dementia, collectively called early Alzheimers disease.

Key Points: 
  • Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced results from the Phase III GRADUATE I and II studies evaluating gantenerumab in people with mild cognitive impairment (MCI) due to Alzheimers and mild Alzheimers dementia, collectively called early Alzheimers disease.
  • This represents a relative reduction in clinical decline of 8% in GRADUATE I and 6% in GRADUATE II compared with placebo.
  • Genentech will present topline findings from the GRADUATE I and II studies at the upcoming Clinical Trials on Alzheimers Disease (CTAD) Conference on Wednesday, November 30, 2022 at 4:15 p.m. PT.
  • Genentech and Roche are investigating more than a dozen medicines for neurological disorders including multiple sclerosis, stroke, Alzheimers disease, Parkinsons disease and autism spectrum disorder.

ALZHEIMER'S ASSOCIATION STATEMENT ON GANTENERUMAB PHASE 3 TOPLINE DATA RELEASE

Retrieved on: 
Monday, November 14, 2022
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CHICAGO, Nov. 14, 2022 /PRNewswire/ -- The Alzheimer's Association is disappointed by the topline Phase 3 data reported today by Genentech and Roche from the GRADUATE Phase 3 global clinical trials of gantenerumab.

Key Points: 
  • CHICAGO, Nov. 14, 2022 /PRNewswire/ -- The Alzheimer's Association is disappointed by the topline Phase 3 data reported today by Genentech and Roche from the GRADUATE Phase 3 global clinical trials of gantenerumab.
  • These results, along with the positive reported data for lecanemab and FDA-approved aducanumab, are valuable for clinicians and researchers.
  • We look forward to learning more about the GRADUATE trials at the Clinical Trials on Alzheimer's Disease (CTAD) meeting later this month.
  • The Alzheimer's Association and the Alzheimer's Impact Movement (AIM) support the bipartisan Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act (S. 1548 / H.R.

Genentech to Present Scientific Progress Across Alzheimer’s Disease Pharmaceutical and Diagnostic Portfolio at 2022 AAIC Annual Meeting

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Thursday, July 28, 2022
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Today, the companies Alzheimers portfolio spans investigational medicines for different targets, types and stages of the disease.

Key Points: 
  • Today, the companies Alzheimers portfolio spans investigational medicines for different targets, types and stages of the disease.
  • GRADUATION, an open-label study to evaluate the pharmacodynamic effects of once weekly administration in participants with early Alzheimers disease.
  • Unlike most Alzheimers disease prevention studies, it enrolls people up to 25 years before the disease has started in the brain.
  • Genentech and Roche are investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, stroke, Alzheimers disease, Parkinsons disease and autism spectrum disorder.

New Spherix Data in Alzheimer's Disease Reveals High Potential for Emerging Anti-Amyloid Therapies from Genentech, Biogen/Eisai, and Eli Lilly, As Well As Novo Nordisk's Semaglutide

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Thursday, July 14, 2022
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EXTON, Pa., July 14, 2022 /PRNewswire/ -- Despite multiple high-profile trial failures in early Alzheimer's disease (AD) over the past several years, the pipeline remains robust, with several mechanisms of action (MOAs) being evaluated. Three late-phase anti-amyloid monoclonal antibodies – Biogen/Eisai's lecanemab, Eli Lilly's donanemab, and Genentech's gantenerumab – are expected to read out over the next year and could help shape this evolving market.

Key Points: 
  • Spherix recently surveyed 100 US neurologists and Alzheimer's disease specialists and followed up with ten qualitative interviews to assess the current and future treatment paradigm for early AD patients.
  • Insights, which are included in the Market Dynamix service, uncover referral patterns, diagnostic tools, drivers of treatment selection, and appetite for emerging therapies (among other factors).
  • Neurologists' high interest in tau-targeting mechanisms could bode well for UCB/Roche's bepranemab, Eli Lilly's LY3372689, and Janssen's JNJ-63733657 if clinical data for these drugs prove positive.
  • Insights highlight market size, current treatment approaches, unmet needs, and expert opinions on the likely disruption introduced by pipeline agents.

Genentech Provides Update on Alzheimer’s Prevention Initiative Study Evaluating Crenezumab in Autosomal Dominant Alzheimer’s Disease

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Thursday, June 16, 2022
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), together with Banner Alzheimers Institute, today announced results from the Alzheimers Prevention Initiative (API) Autosomal Dominant Alzheimer's Disease (ADAD) Colombia Trial.

Key Points: 
  • Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), together with Banner Alzheimers Institute, today announced results from the Alzheimers Prevention Initiative (API) Autosomal Dominant Alzheimer's Disease (ADAD) Colombia Trial.
  • The study evaluated the potential of crenezumab, an investigational medicine, to slow or prevent Alzheimers disease in cognitively unimpaired people who carry a specific genetic mutation which causes early-onset Alzheimers disease.
  • Within its Alzheimers pipeline, Genentech is also evaluating the potential of gantenerumab in autosomal dominant Alzheimers disease, as well as for the prevention of sporadic Alzheimers and treatment of early Alzheimers in late stage clinical trials.
  • The Alzheimers Prevention Initiative (API) is an international collaborative formed in 2009 to launch a new era of Alzheimers prevention research.

Eisai: Latest Findings on Lecanemab Presented at AD/PD 2022 Annual Meeting

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Tuesday, March 22, 2022
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Robust amyloid reduction in those receiving lecanemab in the Core study was maintained while off-treatment over the Gap period.

Key Points: 
  • Robust amyloid reduction in those receiving lecanemab in the Core study was maintained while off-treatment over the Gap period.
  • Lecanemab could potentially be administered at 10mg/kg on the first day of treatment and continue at biweekly intervals without titration.
  • Eisai expects to complete this rolling submission in the first quarter of our fiscal year 2022, which begins April 1, 2022.
  • Additionally, the readout of the Phase 3 confirmatory Clarity AD clinical trial will occur in the Fall of 2022.

LATEST FINDINGS ON LECANEMAB - CLINICAL EFFICACY, ARIA RATES, BIOMARKERS RELATIONSHIP TO CLINICAL OUTCOMES AND DOSING REGIMENS - PRESENTED AT AD/PD™ 2022 ANNUAL MEETING

Retrieved on: 
Monday, March 21, 2022
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Eisai's study design provided the opportunity to explore the biomarker and clinical effects of stopping and restarting lecanemab across five years of disease trajectory.

Key Points: 
  • Eisai's study design provided the opportunity to explore the biomarker and clinical effects of stopping and restarting lecanemab across five years of disease trajectory.
  • Robust amyloid reduction in those receiving lecanemab in the Core study was maintained while off-treatment over the Gap period.
  • Update on Lecanemab Clinical Development, Including New Subcutaneous Formulation
    Eisai's Dr. Michael Irizarry Senior VP of Clinical Research and Deputy Chief Clinical Officer presentedupdates on key lecanemab clinical trials.
  • Eisai expects to complete this rolling submission in the first quarter of our fiscal year 2022, which begins April 1, 2022.

Physician Hesitation to Prescribe Biogen/Eisai's Aduhelm in Alzheimer's Disease Grows Amid Controversies, According to Spherix Global Insights

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Wednesday, December 1, 2021
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Spherix Global Insights, a leading market intelligence firm specializing in neurology-based research and insights, has been tracking Aduhelm since launch through their Launch Dynamix: Aduhelm (Biogen) in Alzheimer's Disease (US) service.

Key Points: 
  • Spherix Global Insights, a leading market intelligence firm specializing in neurology-based research and insights, has been tracking Aduhelm since launch through their Launch Dynamix: Aduhelm (Biogen) in Alzheimer's Disease (US) service.
  • One physician noted, "When we are being detailed, I would say probably more than half of the discussion is all talking about safety.
  • Spherix coverage of the Aduhelm launch continues with fielding beginning today for the second quarterly deep dive survey.
  • In addition, Spherix will assess physicians' proclivity to trial a DMT for the treatment of Alzheimer's disease assuming approval through the accelerated pathway.