AC IMMUNE PARTNER GENENTECH PRESENTS IMPORTANT
DATA ON ALZHEIMER'S THERAPY CRENEZUMAB
- Crenezumab higher dose in CREAD Phase 3 Alzheimer's trial
supported by exposure-response model
- Phase 1b dose-escalation study results support 60mg/kg dose
in CREAD Phase 3
Lausanne, Switzerland, December 9, 2016 - 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. These data were presented at the 9th Clinical
Trials on Alzheimer's disease Conference (CTAD) in San Diego, USA:
they were from a Phase 1b safety study and an exposure-response
model to evaluate the best dose of crenezumab for the treatment of
people with Alzheimer's disease. The model predicts, relative to
the Phase 2 trials, an improved outcome of the CREAD Phase 3
clinical trial in patients with prodromal-to-mild Alzheimer by
using the higher dose of 60mg/kg of crenezumab.
Prof. Andrea Pfeifer, CEO of AC Immune,
commented: "We are impressed by the drug-disease model, as well
as the safety data of the Phase 1b study which further support
the higher dose of crenezumab in the Phase III
trial targeting prodromal-to-mild
Alzheimer patients."
About the crenezumab drug-disease progression
modelGenentech has developed a comprehensive drug-disease
progression model to simulate the Phase 3 clinical trial and
estimate the likelihood of achieving relative reduction in disease
progression in patients treated with different doses of crenezumab,
in different patient populations. The drug-disease model adequately
described the historical longitudinal decline in ADAS-Cog 12[1] and
CDR-SB[2] in mild to moderate AD patients of crenezumab in Phase 2
studies (ABBY/BLAZE).
The clinical trial simulations using the
drug-disease model predict a meaningful response of crenezumab in
patients with mild AD at a dose of 60mg/kg IV every 4 weeks, as
measured by CDR-SB and ADAS-Cog 12. This dose of 60mg/kg IV was
selected by Genentech for the Phase 3 CREAD trial, which started
recruitment of patients in Q1 2016.
About the Phase 1b study resultsGenentech
presented the results of the first two cohorts of the Phase 1b
crenezumab dose escalation study (NCT02353598) in 52 patients with
mild-to-moderate Alzheimer's disease. No dose-limiting toxicities
were observed at 30, 45 and 60mg/kg doses of crenezumab. No events
of Amyloid Related Imaging Abnormality-Edema (ARIA-E) were observed
in the Phase 1b study and only a few patients (6 of 52) showed
asymptomatic Amyloid Related Imaging Abnormality-Hemsiderin(ARIA-H)
which did not result in treatment discontinuation. The
pharmacokinetic profile of crenezumab is dose proportional up to
the 60mg/kg dose and is consistent with historical data. The serum
concentrations at this dose are four fold higher than in the
15mg/kg IV every four weeks dose used in the Phase 2 trials. These
safety and pharmacokinetic data of the Phase 1b dose escalation
study support the continued treatment of patients with crenezumab
at a higher dose of 60mg/kg.
About CrenezumabCrenezumab was discovered
by AC Immune using its SupraAntigen technology platform and
out-licensed to Genentech 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 the effector function, allowing microglia to
clear Abeta from the brain while minimizing an inflammatory
response.
Genentech is currently evaluating the clinical
efficacy and safety of crenezumab in a Phase 3 clinical trial,
CREAD, in 750 participants with prodromal or mild Alzheimer's
disease, which started in Q1 2016 and is expected to read out in
2020. 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 Alzheimer's disease It is becoming increasingly
clear that Alzheimer's disease develops because of a complex series
of events that take place in the brain over a long period of time.
Two proteins - Tau and beta-amyloid (Abeta) - 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.
AD is one of the biggest burdens of society with
a dramatic and growing worldwide incidence rate of one new case
every three seconds, or 9.9 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 2015 there are 46.8 million people living with
dementia and by 2050 it is expected that global patient numbers
will triple to 131.5 million. It is estimated that the annual
societal and economic cost of dementia has risen from US$ 604
billion in 2010 to US$ 818 billion in 2015. In the US, AD is
now the 6th leading cause of death across all ages and is the fifth
leading cause of death for those aged 65 and older.
About AC ImmuneAC Immune is a clinical
stage Swiss-based biopharmaceutical company focused on
neurodegenerative diseases with four product candidates in clinical
trials. The Company designs, discovers and develops therapeutic and
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. The Company's pipeline features seven
therapeutic and three diagnostic product candidates. The most
advanced of these is crenezumab, an anti-Abeta antibody in Phase 3
clinical studies that is being advanced by the collaboration
partner Genentech, Inc., a member of the Roche Group. Other
business partners include Biogen, Janssen Pharmaceuticals, Nestlé
Institute of Health Sciences and Piramal Imaging.
Forward looking statementsThis press
release may contain 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, but are not limited to, the timing and
conduct of clinical trials of AC Immune's product candidates, the
clinical utility of AC Immune's product candidates, the timing or
likelihood of regulatory filings and approvals, AC Immune's
intellectual property position and AC Immune's financial position.
These risks and uncertainties also include those described under
the captions "Risk Factors" and "Management's Discussion and
Analysis of Financial Condition and Results of Operations" in AC
Immune's Registration Statement on Form F-1 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:
Prof. Andrea PfeiferChief Executive OfficerPhone: +41-21-345 91
21E-mail:andrea.pfeifer@acimmune.com |
Eva SchierCorporate Communications ManagerPhone: +41-21-345 91
34Mobile: +41 79 926 66 03E-mail: eva.schier@acimmune.com
|
Nick Miles/ Toomas Kull Cabinet Privé de Conseils s.a.Phone :
+41 22 321 45 40E-mail : miles@cpc-pr.com
kull@cpc-pr.com |
In the USTed AgneThe Communications Strategy Group
Inc.Phone: +1 781 631 3117E-mail: edagne@comstratgroup.com
|
[1] ADAS-Cog 12: Alzheimer's Disease Assessment Scale-cognitive
subscale ADAS-cog is a widely used scale in clinical trials which
measures the patient's performance on tests of memory and other
areas of cognition, especially orientation, praxis and
language.
[2] CDR-SB: Clinical Dementia Rating Scale Sum
of Boxes is an assessment of an overall function of the patient in
daily life. The patient's performance in the six domains of memory,
orientation, judgment and problem solving, community affairs, home
and hobbies and personal care are assessed by interviewing the
patient and caregiver.
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