- Start of Phase 2 trial with ACI-24 in patients with mild
Alzheimer's disease; first patient enrolled
- Recruitment completed for high-dose cohort of Phase 1b study
with ACI-24 for Abeta-related cognitive decline in individuals with
Down Syndrome
Lausanne, Switzerland, August 20, 2018 -
AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage
biopharmaceutical company with a broad pipeline focused on
neurodegenerative diseases, today announced two clinical milestone
events related to ACI-24, its anti-Abeta vaccine against
Alzheimer's disease and Abeta-related cognitive decline in Down
Syndrome.
Prof. Andrea Pfeifer, CEO of AC Immune,
said: "We are delighted with the progress of ACI-24, the anti-Abeta
vaccine, derived from our proprietary SupraAntigenTM platform. In
addition to the development in Alzheimer's Disease, it is currently
the only clinical-stage vaccine targeting the associated
Abeta-induced cognitive decline in people with Down Syndrome.
Vaccines are potentially an important option for the treatment and
prevention of neurodegenerative diseases and are a key asset in our
pipeline."
ACI-24 Vaccine for Alzheimer's DiseaseAC
Immune has started the Phase 2 study with ACI-24 in patients with
mild Alzheimer's disease (AD). The aim of this double-blind,
randomized, placebo-controlled study with an adaptive design is to
assess the safety, tolerability, immunogenicity, target engagement,
biomarkers and clinical efficacy of ACI-24. The trial will seek to
confirm the positive trends on Abeta PET* imaging and clinical
measurement (CDR-SB°) of the previous Phase 1 safety study. The
Phase 2 trial will be conducted in several European countries and
the first patients have been screened.
ACI-24 in Down SyndromeAC Immune has
completed recruitment for the high-dose cohort of the ACI-24
Phase°1b study for the treatment of Alzheimer's disease-like
characteristics in adults with Down Syndrome (DS), a condition
affecting approximately one in 700 newborns. The first low-dose and
the second high-dose cohorts have been fully recruited in August
2017 and in July 2018 respectively, and interim results of the low
dose cohort are expected later in 2018. In addition to cognitive
dysfunction beginning in childhood, individuals with DS are
genetically-predisposed to develop Abeta-related cognitive decline
at a much younger age and with much greater probability than the
general population.
To learn more about the Phase 1b clinical trial (3
Star Study), please visit ClinicalTrials.gov: NCT02738450.
Vaccines are key pipeline assetsVaccines
are potentially an important option for the treatment and
prevention of neurodegenerative diseases with high market
potential. AC Immune's promising pipeline of Abeta- and
Tau-targeted therapies includes new diagnostic and treatment
options, including various vaccines. ACI-24 is the Company's first
vaccine entering in Phase 2 development. It enhances AC Immune's
late stage clinical pipeline, containing one Phase 3 and multiple
Phase 2 product candidates. We believe the pipeline is therefore
well positioned to target both Abeta and Tau in a combined approach
for a disease-modifying AD treatment.
About ACI-24ACI-24 is a liposomal
therapeutic anti-Abeta vaccine candidate, which generates
antibodies specific to disease-causing conformations. The vaccine
is designed to stimulate a patient's immune system to produce
antibodies that specifically target the oligomeric and fibrillary
Abeta proteins to prevent plaque accumulation and to enhance plaque
clearance. Preclinical data demonstrated a significant activity in
plaque reduction and memory restoration as well as a favorable
safety profile characterized by a lack of local inflammation and a
mode of action independent of T-cells. The vaccine is being studied
in a Phase 2 clinical trial in patients with mild to moderate AD
and in a Phase 1b study in young adult DS subjects, and has been
proven to be safe with preliminary trends of efficacy.
About Alzheimer's disease Evidence shows
that AD develops because of a complex series of events that take
place in the brain over an extended time-period. Two proteins -
beta-amyloid (Abeta) and Tau°- are recognized as major hallmarks of
neurodegeneration: tangles and other abnormal forms of Tau protein
accumulate inside the brain cells and spread between cells, while
plaques and oligomers formed by beta-amyloid occur outside the
brain cells of people with AD.
Alzheimer's disease is one of the biggest
burdens of society with a dramatic and growing worldwide incidence
rate of one new case every three seconds, or nearly 10 million new
cases of dementia each year. Since the incidence and prevalence of
AD increase with age, the number of patients will grow
significantly as society ages. Worldwide in 2018 there were 50
million people living with dementia and by 2050 it is expected that
global patient numbers will triple to 152 million1. It is estimated
that the annual societal and economic cost of dementia has risen
from USD 818 billion in 2015 to USD 1 trillion in 20181.
About Down SyndromeIndividuals with Down
Syndrome have an extra copy of chromosome 21 which carries the gene
for the Amyloid Beta Precursor Protein (APP) encoding the precursor
protein of Abeta, one of the hallmarks of AD. An important
consequence is that almost all subjects with Down Syndrome older
than 40 years exhibit neuropathological changes similar to AD, in
the form of senile plaque formation and neurofibrillary tangles2,3.
It is estimated that there are 6 million people with DS worldwide,
with 250,000 in the United States4.
*Positron Emission Tomography; °Clinical
Dementia Rating-Sum of Boxes
References1
World Health Organization (WHO); Alzheimer's Disease International
(ADI)2 Head E,
Powell D, Gold BT, Schmitt FA. Alzheimer's Disease in Down
Syndrome. European journal of neurodegenerative disease.
2012;1(3):353-3643
Castro P, Zaman S, Holland A. Alzheimer's disease in people with
Down's syndrome: the prospects for and the challenges of developing
preventative treatments. Journal of Neurology.
2017;264(4):804-8134
Presson AP, Partyka G, Jensen KM, Devine OJ, Rasmussen SA, McCabe
LL, McCabe ER.Parker. Current estimate of Down Syndrome population
prevalence in the United States. The Journal of Pediatrics. 2013
Oct;163(4):1163-8
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)
and Parkinson's Disease. 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 Communications
Phone: +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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