Novo Nordisk to enter phase 3 development in Alzheimer’s disease with oral semaglutide
December 16 2020 - 8:07AM
Novo Nordisk to enter phase 3 development in Alzheimer’s disease
with oral semaglutide
Bagsværd, Denmark, 16 December 2020 – Novo
Nordisk today announced the decision to enter phase 3 development
in Alzheimer’s disease with 14 mg oral semaglutide, a once-daily
oral formulation of the long-acting GLP-1 analogue semaglutide. The
decision follows evaluation of GLP-1 data from preclinical models,
real-world evidence studies, post-hoc analysis of data from large
cardiovascular outcomes trials, as well as discussions with
regulatory authorities.
Novo Nordisk intends to initiate a pivotal phase 3a programme
with approximately 3,700 people with early Alzheimer’s disease. The
programme is planned for initiation in the first half of 2021 and
will investigate the efficacy and safety of once-daily oral
semaglutide, compared to placebo. The expected main treatment
period in the trials is around two years.
“As a company we aspire to address high unmet medical needs
within serious chronic diseases, and we are therefore pleased to
initiate phase 3 development of semaglutide within Alzheimer’s
disease,” said Mads Krogsgaard Thomsen, executive vice president
and chief scientific officer at Novo Nordisk. “Alzheimer’s disease
has been an area of extensive research in the past decades,
unfortunately without any major medical breakthroughs. Due to the
growing unmet medical need and the increasing evidence of a
potential therapeutic role for GLP-1, we will investigate the
benefits of oral semaglutide in early Alzheimer’s disease.”
Conference callOn 16 December at 4 pm CET,
corresponding to 10 am EST, a conference call for investors will be
held where members of management will elaborate on the decision and
provide a brief update on the GLP-1 R&D strategy. Investors
will be able to listen in via a link on the investor section of
novonordisk.com.
About Alzheimer’s diseaseAlzheimer’s disease
represents a rapidly growing public health concern causing
significant detrimental consequences to the affected people and
their families and has led to substantial and increasing global
socioeconomic impact. Worldwide, 70-100 million people are
estimated to have early Alzheimer’s disease (mild cognitive
impairment and mild dementia stages).
About data from preclinical models, real-world evidence
studies and the post-hoc analysisAnimal studies highlight
the key effects of GLP-1 relevant for Alzheimer’s disease including
improved memory function and reduced phospho-tau accumulation.
Semaglutide has specifically been shown to reduce measures of
neuro-inflammation which may affect cognition and function.
Further, real-world evidence from two Danish nationwide
registries, the US Truven claims database and the US FDA FAERS
database support a potential association between lower risk of
dementia following treatment with GLP-1.
Finally, in a post-hoc analysis of data from three large
cardiovascular outcomes trials conducted by Novo Nordisk (LEADER,
SUSTAIN 6 and PIONEER 6), which included 15,820 patients with type
2 diabetes with median follow-up of 3.6 years, a total number of 47
people were identified with development of dementia, of which 32
were on placebo and 15 on GLP-1 (liraglutide or semaglutide). The
rate of developing dementia was statistically significantly reduced
by 53% in favour of GLP-1.
About oral semaglutideOral semaglutide (7 mg
and 14 mg) is approved as an adjunct to diet and exercise to
improve glycaemic control in adults with type 2 diabetes in the US,
EU and Japan. The approval of Rybelsus® is based on the results
from 10 clinical trials which included 9,543 adults with type 2
diabetes. Rybelsus® demonstrated a safe and well-tolerated profile
across the clinical trials, with the most common adverse event
being mild to moderate nausea which diminished over time.
Novo Nordisk is a leading global healthcare company, founded in
1923 and headquartered in Denmark. Our purpose is to drive change
to defeat diabetes and other serious chronic diseases such as
obesity and rare blood and endocrine disorders. We do so by
pioneering scientific breakthroughs, expanding access to our
medicines and working to prevent and ultimately cure disease. Novo
Nordisk employs about 44,000 people in 80 countries and markets its
products in around 170 countries. Novo Nordisk's B shares are
listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the
New York Stock Exchange (NVO). For more information, visit
novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.
Further information
Media: |
|
|
Mette Kruse
Danielsen |
+45 3079 3883 |
mkd@novonordisk.com |
Ken Inchausti
(US) |
+1 609 240
9429 |
kiau@novonordisk.com |
|
|
|
Investors: |
|
|
Daniel Muusmann
Bohsen |
+45 3075 2175 |
dabo@novonordisk.com |
Valdemar Borum
Svarrer |
+45 3079 0301 |
jvls@novonordisk.com |
Ann Søndermølle
Rendbæk |
+45 3075 2253 |
arnd@novonordisk.com |
Mark Joseph
Root |
+45 3079 4211 |
mjhr@novonordisk.com |
Kristoffer Due
Berg (US) |
+1 609 235
2989 |
krdb@novonordisk.com |
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