Crenezumab's Second Phase 3 Trial (CREAD 2) Fully Recruited - Updates on AC Immune's Pipeline and Technology Platforms to be ...
July 17 2018 - 4:01AM
Crenezumab's Second Phase 3 Trial (CREAD 2)
Fully Recruited-Updates on AC Immune's Pipeline and
Technology Platforms to be presented at the Alzheimer's Association
International Conference in Chicago
Lausanne, Switzerland, July 17, 2018 - AC
Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage
biopharmaceutical company focused on neurodegenerative diseases,
today announced that the second Phase 3 (CREAD 2) clinical trial of
crenezumab, AC Immune's anti-Abeta antibody candidate for treatment
of Alzheimer's disease, conducted by its partner Genentech, a
member of the Roche Group, has completed global recruitment.
Prof. Andrea Pfeifer, CEO of AC Immune,
commented: "We are very happy that the CREAD 2 recruitment has been
completed ahead of schedule. This clearly shows the strong
commitment of our partner Roche/Genentech to the development of
crenezumab as a potential disease-modifying therapy for Alzheimer's
disease - one of society's biggest healthcare challenges."
The following updates on AC Immune's advancement
of its in-house and partnered product candidates and technology
platforms including crenezumab, will be presented at the
Alzheimer's Association International Conference (AAIC© 2018). The
conference is the largest international meeting dedicated to
advancing dementia science and takes place in Chicago, US, from
July 22nd to 26th, 2018:
Program and Collaborator |
Presentations and Timing |
Tau PET Imaging agent / Piramal/InviCRO |
Clinical Update: 18f-PI-2620, a Next Generation Tau PET Agent
Evaluated in Subjects with Alzheimer's Disease and Progressive
Supranuclear Palsy Poster - July 21 / 12:30pm -
1:45pm (CDT) Session: IC-P-220 / Hall: F1 |
Crenezumab /Genentech/Roche |
Baseline characteristics from a phase 3 trial of crenezumab
in prodromal to mild Alzheimer's disease (CREAD) Oral
presentation - July 22 / 8:45pm - 9:00pm (CDT)Session:
O1-02-04 / Room: 183 |
Alpha-synuclein PET tracers / AC Immune |
Novel alpha-synuclein Positron Emission Tomography (PET)
tracers for the Diagnosis of Parkinson's Disease Oral
presentation - July 25 / 3:15pm - 3:30pm
(CDT) Session: DT-01-06 / Hall: W375 E |
Crenezumab /Genentech |
Target Engagement in an AD Trial: Crenezumab Lowers Aß
Oligomer Levels in CSF Oral presentation - July 25 / 4:45pm
- 5:00pm (CDT)Session: DT-01-03 / Hall: W375 E |
About CrenezumabCrenezumab is an
anti-Abeta antibody discovered by AC Immune using its
SupraAntigen(TM) technology platform and out-licensed to Genentech,
a member of the Roche group, in 2006 as a potential therapy for
Alzheimer's disease. Crenezumab is a fully humanized IgG4
monoclonal antibody that binds all forms of misfolded Abeta
proteins, but especially to Abeta oligomers, to prevent and break
up Abeta aggregation and promote Abeta disaggregation. The IgG4
subclass has reduced effector function, allowing microglia to clear
Abeta from the brain while minimizing an inflammatory response.
Roche/Genentech is currently evaluating the
clinical efficacy and safety of crenezumab in two Phase 3 clinical
trials, CREAD 1 and 2, in 750 participants each trial with
prodromal or mild Alzheimer's disease, which started in the first
quarter of 2016 and the first quarter of 2017, respectively. CREAD
1 was fully recruited in the fourth quarter of 2017 and CREAD 2
completed global recruitment in July 2018. In addition, crenezumab
was chosen by an international panel of experts, including the US
National Institutes of Health, for use in a first-ever prevention
trial in Alzheimer's disease in a large extended family in Colombia
(API ADAD) in 2012.
About AC ImmuneAC Immune is a
clinical-stage Swiss-based biopharmaceutical company, listed on
Nasdaq, which aims to become a global leader in precision medicine
for neurodegenerative diseases. The Company designs, discovers and
develops therapeutic as well as diagnostic products intended 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 product candidates - with five product candidates
currently in clinical trials. The most advanced of these is
crenezumab, a humanized anti-amyloid-ß monoclonal IgG4 antibody
that targets monomeric and aggregated forms of amyloid-ß, with
highest affinity for neurotoxic oligomers. Crenezumab is currently
in two Phase 3 clinical studies for AD, under a global program
conducted by the collaboration partner Genentech (a member of the
Roche Group). Other collaborations include Biogen, Janssen
Pharmaceuticals, Nestlé Institute of Health Sciences, Piramal
Imaging and Essex Bio-Technology.
Forward looking statements This press
release contains statements that constitute "forward-looking
statements" within the meaning of Section 27A of the Securities Act
of 1933 and Section 21E of the Securities Exchange Act of 1934.
Forward-looking statements are statements other than historical
fact and may include statements that address future operating,
financial or business performance or AC Immune's strategies or
expectations. In some cases, you can identify these statements by
forward-looking words such as "may," "might," "will," "should,"
"expects," "plans," "anticipates," "believes," "estimates,"
"predicts," "projects," "potential," "outlook" or "continue," and
other comparable terminology. Forward-looking statements are based
on management's current expectations and beliefs and involve
significant risks and uncertainties that could cause actual
results, developments and business decisions to differ materially
from those contemplated by these statements. These risks and
uncertainties include those described under the captions "Item 3.
Key Information-Risk Factors" and "Item 5. Operating and Financial
Review and Prospects" in AC Immune's Annual Report on Form 20-F and
other filings with the Securities and Exchange Commission.
Forward-looking statements speak only as of the date they are made,
and AC Immune does not undertake any obligation to update them in
light of new information, future developments or otherwise, except
as may be required under applicable law. All forward-looking
statements are qualified in their entirety by this cautionary
statement.
For further information, please
contact:
In EuropeBeatrix BenzAC Immune Corporate
CommunicationsPhone: +41 21 345 91 34E-mail:
beatrix.benz@acimmune.com |
In the USLisa SherAC Immune Investor RelationsPhone: +1 970
987 26 54E-mail: lisa.sher@acimmune.com |
Nick Miles/Toomas KullCabinet Privé de Conseils s.a.Phone: +41 22
552 46 46 E-mail: miles@cpc-pr.com kull@cpc-pr.com
|
Ted AgneThe Communications Strategy Group Inc.Phone: +1 781 631
3117E-mail: edagne@comstratgroup.com |
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