Full Press Release Details
AC Immune Reports Discontinuation of Phase
III CREAD 1 and 2 Studies of Crenezumab in Alzheimer's Disease
Lausanne, Switzerland, January 30, 2019
- AC Immune SA (NASDAQ:ACIU) announced today that Roche, the parent company of its collaboration partner, is discontinuing
the CREAD 1 and CREAD 2 (BN29552 and BN 29553) Phase III studies of the investigational anti-beta-amyloid molecule, crenezumab,
in people with prodromal to mild sporadic Alzheimer's disease (AD). The decision came after an interim analysis conducted
by the Independent Data Monitoring Committee (IDMC). Alzheimer's disease (AD) is a progressive, fatal disease that gradually
destroys memory, thinking skills and problem solving, and impairs daily functioning such as the ability to manage one's own
The IDMC analysis indicated that crenezumab
was unlikely to meet its primary endpoint of change from baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score. This
decision was not related to safety of the investigational product. No safety signals for crenezumab were observed in this analysis
and the overall safety profile was similar to that seen in previous trials.
Crenezumab continues to be studied in a
landmark trial of cognitively healthy individuals in Colombia with an autosomal dominant mutation who are at risk of developing
familial AD (fAD), under the Alzheimer's Prevention Initiative (API), which began in 2013. This study will determine if treating
people carrying this mutation with crenezumab prior to the onset of AD symptoms will slow or prevent the decline of cognitive and
functional abilities. This study is in collaboration with the Banner Institute and is funded by the National Institute on Aging.
Data from the CREAD 1 and 2 studies will
be made available to the scientific community by Roche at an upcoming scientific meeting. AC Immune looks forward to receiving
and reviewing the data in detail and sharing it as appropriate following peer review.
CREAD 1 and 2 were two-year global, randomized,
double-blind, placebo-controlled, parallel-group Phase III studies testing the efficacy and safety of crenezumab in 1,500 patients
worldwide with early AD with confirmed evidence of cerebral beta amyloid pathology (CSF or amyloid PET). These studies used doses
four times higher than that studied in the Phase II trials. CREAD 1 was initiated in early 2016 and CREAD 2 in mid-2017.
As reported by Roche today, the TAURIEL
Phase II trial of an anti-tau antibody (RG-6100) in Alzheimer's disease, run by Roche in partnership with AC Immune will
Prof. Andrea Pfeifer, CEO of AC Immune,
said: "We are extremely disappointed about the outcome of the Phase III CREAD 1 interim analysis and we also would like to
thank patients and caregivers for their participation. We continue to be optimistic about the potential future of crenezumab as
we await the outcome of the Colombian API study to prevent AD symptoms in patients with familial AD to see if the antibody treatment
may provide disease-modifying effects in patients with early-onset disease."
Dr. Pfeifer continued, "We remain
committed to our on-going pre-clinical and clinical candidates targeting Tau and neuro-inflammation to treat Alzheimer's
disease, neuro-orphan diseases and Parkinson's disease, which are partnered with five leading pharmaceutical partners, including
Roche's subsidiary Genentech."
About the Molecules and Development Programs
in Collaboration with Roche
The development of crenezumab is being led
by Roche and was discovered by AC Immune SA. The companies entered into a research collaboration and license agreement as of November
6, 2006. Crenezumab is an investigational, monoclonal antibody designed to preferentially bind to and promote removal of neurotoxic
oligomers, a form of beta-amyloid. Crenezumab has an antibody backbone (IgG4) designed to minimize the inflammatory response in
the brain, which may result in a lower risk of certain MRI (magnetic resonance imaging) abnormalities known as ARIA (Amyloid-Related
Imaging Abnormalities).
RG6100 (anti-tau) is an investigational,
monoclonal IgG4 antibody that binds to multiple tau species. This antibody is also part of a collaboration with Roche. It is proposed
to slow the prion-like propagation of tau pathology in AD. Tau pathology spreads with a characteristic spatiotemporal pattern throughout
the brain, coinciding with both clinical symptoms and disease progression in AD. Slowing the propagation of tau pathology may therefore
slow disease progression and reduce cognitive decline. Anti-tau therapies have shown progress in slowing the progression of tau
pathology in animal models of tauopathy. RG6100 is currently in Phase II clinical evaluation for its potential to slow or stop
the progression of AD.
AC Immune is a NASDAQ-listed, clinical-stage
biopharmaceutical company, with a vision to deliver precision medicine to people around the globe with neurodegenerative diseases.
The company designs, discovers and develops therapeutic and diagnostic products to prevent and modify diseases caused by misfolding
proteins. AC Immune's two proprietary technology platforms create antibodies, small molecules and vaccines designed to address
a broad spectrum of neurodegenerative indications, such as Alzheimer's disease (AD). The company's pipeline features
nine therapeutic and three diagnostic candidates - with five products in clinical trials.
For further information, please contact:
| In Europe David Lowe AC Immune Corporate Communications Phone: +41 21 345 91 21 E-mail: david.lowe@acimmune.com | US Investors Lisa Sher AC Immune Investor Relations Phone: +1 970 987 26 54 E-mail: lisa.sher@acimmune.com |
| European Investors & Media Chris Maggos LifeSci Advisors Phone: +41 79 367 6254 E-mail: chris@lifesciadvisors.com | US Media Katie Gallagher LaVoieHealthScience Phone: +1 617 792 3937 E-mail: kgallagher@lavoiehealthscience.com |
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