Drugs / Crenezumab
last change Aug 2023 re-read 3 minutes ago

Crenezumab

also known as MABT5102A · RG-7412

Monoclonal antibody targets APP via inhibition

Developed for
Alzheimer disease
Investigated by
Genentech, Inc. · Hoffmann-La Roche · Banner Alzheimer's Institute · National Institute on Aging (NIA)

Trials 12

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT02427243 Apr → Jul 2015 — Genentech, Inc. Completed No outcome recorded
Phase 1 NCT02353598 Feb 2015 → Nov 2016 Alzheimer disease Genentech, Inc. Completed No outcome recorded
Phase 1 NCT00997919 Oct 2009 → Feb 2010 — Genentech, Inc. Completed No outcome recorded
Phase 1 NCT00736775 Aug 2008 → May 2010 Alzheimer disease Genentech, Inc. Completed No outcome recorded
Phase 25 trials · 3 missed
Phase 2 NCT03977584 Jun 2019 → Apr 2022 Alzheimer disease Hoffmann-La Roche Completed Missed primary
Phase 2 NCT01998841 Dec 2013 → Mar 2022 Alzheimer disease Genentech, Inc. Completed Missed primary
Phase 2 NCT01723826 Dec 2012 → Feb 2017 Alzheimer disease Genentech, Inc. Completed No outcome recorded
Phase 2 NCT01397578 Aug 2011 → Apr 2014 Alzheimer disease Genentech, Inc. Completed Missed primary
Phase 2 NCT01343966 Apr 2011 → Feb 2014 Alzheimer disease Genentech, Inc. Completed No outcome recorded
Phase 33 trials · 1 missed
Phase 3 NCT03491150 Apr 2018 → May 2019 Alzheimer disease Hoffmann-La Roche Terminated No outcome recorded
Phase 3 NCT03114657 Mar 2017 → Jun 2019 Alzheimer disease Hoffmann-La Roche Terminated No outcome recorded
Phase 3 NCT02670083 Mar 2016 → May 2019 Alzheimer disease Hoffmann-La Roche Terminated Missed primary

News releases announcing trial results or a regulatory action · 8

DateIssuerRelease
2022-08-02 AC Immune SA Results Detailed Data From the Phase II Crenezumab Alzheimer’s Prevention Initiative Study in Autosomal Dominant Alzheimer’s Disease Presented at AAIC acimmune.com ↗
As previously reported on June 16, 2022 , the trial did not meet its co-primary endpoints (API ADAD composite cognitive total score and the Free and Cued Selective Reminding Test Cueing Index).
2022-06-16 Hoffmann-La Roche Results Roche provides update on Alzheimer’s Prevention Initiative study evaluating crenezumab in autosomal dominant Alzheimer’s disease roche.com ↗
The trial did not demonstrate a statistically significant clinical benefit in either of its co-primary endpoints assessing the rate of change in cognitive abilities or episodic memory function, measured by the API ADAD composite cognitive score and the Free and Cued Selective Reminding Test (FCSRT) Cueing Index, respectively.
2022-06-16 AC Immune SA Results AC Immune Provides Update on Alzheimer’s Prevention Initiative Study Evaluating Crenezumab in Autosomal Dominant Alzheimer’s Disease acimmune.com ↗
Crenezumab did not statistically significantly slow or prevent cognitive decline in people with a specific genetic mutation which causes early-onset Alzheimer’s disease
2022-06-15 Genentech, Inc. Results Genentech Provides Update on Alzheimer’s Prevention Initiative Study Evaluating Crenezumab in Autosomal Dominant Alzheimer’s Disease gene.com ↗
The trial did not demonstrate a statistically significant clinical benefit in either of its co-primary endpoints assessing the rate of change in cognitive abilities or episodic memory function, measured by the API ADAD composite cognitive score and the Free and Cued Selective Reminding Test (FCSRT) Cueing Index, respectively.
2019-01-30 Hoffmann-La Roche Results Roche to discontinue Phase III CREAD 1 and 2 clinical studies of crenezumab in early Alzheimer's disease (AD) - other company programmes in AD continue roche.com ↗
No safety signals for crenezumab were observed in this analysis and the overall safety profile was similar to that seen in previous trials.
2019-01-29 Genentech, Inc. Results Genentech to Discontinue Phase III CREAD 1 and 2 Clinical Studies of Crenezumab in Early Alzheimer’s Disease (AD) - Other Company Programs in AD Continue gene.com ↗
2018-07-19 Genentech, Inc. Results Genentech to Present New Data Demonstrating the Breadth and Depth of Its Alzheimer’s Program at the Upcoming Alzheimer's Association International Conference (AAIC) gene.com ↗
Late-breaking Phase II exploratory analysis of investigational crenezumab to show impact on beta amyloid oligomer levels in cerebral spinal fluid (CSF)
2016-12-09 AC Immune SA Results AC IMMUNE PARTNER GENENTECH PRESENTS IMPORTANT DATA ON ALZHEIMER'S THERAPY CRENEZUMAB acimmune.com ↗
AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical stage biopharmaceutical company focused on neurodegenerative diseases, today announced that its partner Genentech, member of Roche group, has presented important data to support the unique binding and increased dosing of its Alzheimer's therapy on crenezumab, an anti-Abeta antibody.

All press releases naming this drug 9 releases

DateIssuerRelease

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 14 sources stand behind the page.

FieldValueCited text
Known as Crenezumab ClinicalTrials.gov intervention name — accepted as the source's own label NCT02670083 ↗
7

NCT03491150 ↗

NCT02353598 ↗

NCT03977584 ↗

NCT01723826 ↗

NCT02427243 ↗

NCT03114657 ↗

NCT01998841 ↗

Known as MABT5102A “Intravenous MABT5102A Administered in a Single-Dose, Dose-Escalation Stage” NCT00736775 ↗
3

NCT00997919 ↗

NCT01397578 ↗

NCT01343966 ↗

Known as RG-7412 ChEMBL registry synonym — accepted as the source's own label CHEMBL1743004 ↗
Action Inhibit “Amyloid-beta A4 protein inhibitor” CHEMBL1743004 ↗
1

“Anti-Abeta (MABT5102A)” NCT00736775 ↗

Modality Monoclonal antibody “crenezumab, a fully humanized anti-beta-amyloid (Aβ) immunoglobulin G4 (IgG4) monoclonal antibody” PMID 31969177 ↗ Jan 2020
Route Intravenous “Intravenous single and multiple doses” NCT00736775 ↗
Target APP “Amyloid-beta A4 protein inhibitor” CHEMBL1743004 ↗