Roche to discontinue Phase III CREAD 1 and 2 clinical studies of crenezumab in early Alzheimer's disease (AD) - other company...
30 Janeiro 2019 - 04:00AM
F. Hoffmann-La Roche Ltd / 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 . Processed and
transmitted by West Corporation. The issuer is solely responsible
for the content of this announcement.
-
The Alzheimer's Prevention
Initiative (API) study of crenezumab in familial Alzheimer's
disease continues
-
Roche remains committed to
ongoing clinical studies in Alzheimer's disease, including GRADUATE
Phase III trials with gantenerumab and the TAURIEL Phase II
anti-tau trial
Basel, 30 January 2019 - Roche (SIX: RO, ROG;
OTCQX: RHHBY) today announced the decision to discontinue CREAD I
and CREAD 2 (BN29552 and BN29553) Phase III studies of the
investigational anti-beta-amyloid molecule crenezumab in people
with early (prodromal to mild) sporadic Alzheimer's disease (AD).
The decision was based on the results of a pre-planned interim
analysis assessing the safety and efficacy of crenezumab conducted
by the Independent Data Monitoring Committee, which indicated that
crenezumab was unlikely to meet the primary endpoint of change from
baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score.
No safety signals for crenezumab were observed in this analysis and
the overall safety profile was similar to that seen in previous
trials.
Data from the CREAD 1 and 2 studies will be shared with the
scientific community at an upcoming medical congress. Findings from
the trials will inform future research programmes, approaches and
clinical trial designs.
"While the results with crenezumab are disappointing, they
meaningfully contribute to our understanding of Alzheimer's
disease," said Sandra Horning, MD, Chief Medical Officer and Head
of Global Product Development at Roche. "We gratefully acknowledge
the participants in the CREAD trials and the efforts of everyone
involved in this important programme. We remain dedicated to the
Alzheimer's community and will continue our Phase III GRADUATE
trials with gantenerumab and Phase II TAURIEL trial with the
anti-tau molecule RG6100, as well as our imaging and fluid-based
diagnostic solutions."
CREAD 1 and 2 are two-year global, randomized, double-blind,
placebo-controlled, parallel-group Phase III studies testing the
efficacy and safety of crenezumab in 1,500 people worldwide with
early AD with confirmed evidence of cerebral beta amyloid pathology
(CSF or amyloid PET). These studies use 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.
Crenezumab continues to be studied in the Alzheimer's Prevention
Initiative (API) trial investigating a different study population
from that of the CREAD programme, namely cognitively healthy
individuals in Colombia with an autosomal dominant mutation who are
at risk to develop familial AD (ADAD). The five-year study is in
collaboration with the Banner Institute and is funded by the
National Institute on Aging.
About the molecules and development programmes
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 minimise 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). Crenezumab is being
developed by Roche and was discovered by Swiss biotechnology
company AC Immune SA.
Gantenerumab is an investigational, IgG1 monoclonal antibody, which
has a distinct mechanism of action from crenezumab. It is designed
to bind to aggregated forms of beta-amyloid and has previously
demonstrated amyloid plaque lowering in AD patients. The clinical
significance of this effect is being investigated in two Phase III
studies (GRADUATE 1 and 2), which are assessing the safety and
efficacy of subcutaneous gantenerumab for the treatment of early AD
patients. The GRADUATE programme is currently enrolling more than
1,500 patients in up to 350 study centres in more than 30 countries
worldwide. Gantenerumab is the only late stage anti-amyloid
programme being developed with subcutaneous administration, which
may, if approved, enable home administration for the patients and
caregivers affected by this disease. Data readout is expected in
2022. Gantenerumab is also being studied in the Dominantly
Inherited Alzheimer Network Trials Unit (DIAN-TU) trial, a global
clinical study evaluating multiple compounds in individuals at risk
for or with fAD.
RG6100 (anti-tau) is an investigational, monoclonal IgG4 antibody
that binds to multiple tau species. This antibody is also part of a
collaboration with AC Immune SA. 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 promise 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.
About Alzheimer's disease
Alzheimer's disease (AD) is a progressive, fatal disease of the
brain that gradually destroys memory, thinking skills and problem
solving, and impairs daily functioning such as the ability to
manage one's own activities. Biological changes in the brain are
believed to start decades before clinical symptoms of AD become
evident. In the early stages (prodromal to mild), people may have
difficulty remembering; their daily function may or may not be
impaired but independence is maintained. In the later stage of the
disease, people increasingly become reliant on others for even
simple day-to-day tasks. Dementia affects 50 million people
worldwide with 10 million new cases each year, of which AD is the
most common form. There is no cure for AD. Current treatments focus
on alleviating symptoms but are unable to stop the progression of
AD because they do not affect the disease's underlying
causes.
About Roche
Roche is a global pioneer in
pharmaceuticals and diagnostics focused on advancing science to
improve people's lives. The combined strengths of pharmaceuticals
and diagnostics under one roof have made Roche the leader in
personalised healthcare - a strategy that aims to fit the right
treatment to each patient in the best way possible.
Roche is the world's largest biotech company, with truly
differentiated medicines in oncology, immunology, infectious
diseases, ophthalmology and diseases of the central nervous system.
Roche is also the world leader in in vitro diagnostics and
tissue-based cancer diagnostics, and a frontrunner in diabetes
management.
Founded in 1896, Roche continues to search for better ways to
prevent, diagnose and treat diseases and make a sustainable
contribution to society. The company also aims to
improve patient access to medical innovations by working with
all relevant stakeholders. Thirty medicines developed by Roche are
included in the World Health Organization Model Lists of Essential
Medicines, among them life-saving antibiotics, antimalarials and
cancer medicines. Moreover, for the tenth consecutive year, Roche
has been recognised as the most sustainable company in the
Pharmaceuticals Industry by the Dow Jones Sustainability Indices
(DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in
over 100 countries and in 2017 employed about 94,000 people
worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and
posted sales of CHF 53.3 billion. Genentech, in the United States,
is a wholly owned member of the Roche Group. Roche is the majority
shareholder in Chugai Pharmaceutical, Japan. For more information,
please visit www.roche.com.
All trademarks used or mentioned in this release are protected by
law.
Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail:
media.relations@roche.com
- Nicolas Dunant (Head)
- Patrick Barth
- Ulrike Engels-Lange
- Simone Oeschger
- Anja von Treskow
Roche-Media-Release_CREN_EN
This
announcement is distributed by West Corporation on behalf of West
Corporation clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: F. Hoffmann-La Roche Ltd via Globenewswire
--- End of Message ---
F. Hoffmann-La Roche Ltd
Grenzacherstrasse 124 Basel Switzerland
ISIN: CH0012032113;
Rogers (NYSE:ROG)
Gráfico Histórico do Ativo
De Fev 2024 até Mar 2024
Rogers (NYSE:ROG)
Gráfico Histórico do Ativo
De Mar 2023 até Mar 2024