Sosei to Advance Clinical Development in Japan of HTL0018318 in Patients with Dementia with Lewy Bodies (DLB)
09 Novembre 2017 - 07:35AM
Business Wire
Amendment of global R&D and
commercialisation partnership between Heptares and Allergan
designed to expand clinical development of HTL0018318 in major
dementia indication
HTL0018318 is a novel muscarinic M1 receptor
agonist in clinical development as a potential treatment for
cognitive impairment in Alzheimer’s disease
Sosei Group Corporation (“Sosei”); TSE Mothers Index:4565)
announces that it has agreed with Allergan to an amendment to the
2016 global R&D and commercialisation partnership between
Allergan and Sosei’s subsidiary Heptares Therapeutics, in which
Allergan gained exclusive rights to Heptares’ broad portfolio of
novel subtype-selective muscarinic receptor agonists in development
for the treatment of major neurological disorders, including
Alzheimer’s disease (AD).
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The amendment sees Sosei gain a licence to develop and
commercialise HTL0018318, a novel muscarinic M1 receptor agonist,
in Japan as a potential new treatment for patients with dementia
with Lewy bodies (DLB). Initially, Sosei will undertake a Phase 2
proof-of-concept monotherapy study, expected to begin in Japan in
2018. Allergan has retained the right to develop HTL0018318 in DLB
globally.
DLB is the second most common form of degenerative dementia
after AD and relates to dementia associated with the presence of
Lewy bodies (abnormal deposits of a protein called alpha-synuclein)
in the brain that affect behaviour, cognition and movement. In DLB,
loss of presynaptic cholinergic (acetylcholine-producing) neurons
is thought to be a key driver of disease symptoms. As in AD,
postsynaptic neurons and muscarinic receptors in DLB are preserved,
which presents an important opportunity for a selective M1 agonist
based approach.
DLB affects up to an estimated 20-30% of all dementia patients.
In Japan, this represents approximately 920,000 individuals, and in
the US approximately 1.4 million individuals. There are no approved
therapies for DLB in the US or Europe, while branded donepezil
(Aricept®, Eisai) is conditionally approved in Japan.
Commenting on the announcement, Peter Bains, CEO at Sosei, said:
“This is a very exciting development in our partnership with
Allergan. It provides Sosei with a major go-to-market opportunity
for our lead program, which is consistent with our growth strategy.
Sosei has developed an extensive understanding of the DLB
opportunity in Japan, and alongside our clinical development
capabilities and track record of successful product development in
Japan we believe we can add significant value to the M1 agonist
program overall through this activity.”
Notes to Editors
About Muscarinic receptorsMuscarinic receptors are G
protein-coupled receptors (GPCRs) found in multiple tissues. Until
now, attempts to develop medicines that target M1 and M4 receptors
have been unsuccessful because of side effects caused by the
activation of M2 and M3 receptors. Selective M1 or M4 agonists that
do not activate M2 or M3 therefore are highly sought after, and
expected to address blockbuster markets.
About the Heptares Therapeutics and Allergan
PartnershipHeptares Therapeutics and Allergan entered a global
R&D and commercialisation partnership in April 2016 under which
Allergan licensed exclusive global rights to Heptares’ broad
portfolio of novel subtype-selective muscarinic receptor agonists
(M1, M4 and dual M1/M4 agonists) in development for the treatment
of major neurological disorders, including Alzheimer’s disease.
The companies are advancing a program evaluating a selective M1
agonist (HTL0018318) through clinical studies as a potential
treatment for symptomatic cognitive deficits in Alzheimer’s
patients; a clinical program to assess the potential of a selective
M4 agonist (HTL0016878) to treat certain neurobehavioural symptoms
of Alzheimer’s disease; and are developing dual M1/M4 agonists with
potential to treat both cognitive and neurobehavioural symptoms
through preclinical studies.
In addition, Sosei plans to initiate a Phase 2 clinical study
with HTL0018318 in patients with dementia with Lewy bodies in
Japan.
About SoseiSosei Group Corporation is an international
biopharmaceutical company originating from Japan that discovers and
develops innovative biopharmaceuticals for the treatment of
Alzheimer's disease, schizophrenia, cancer, migraine, addiction,
metabolic disease, and other indications. By utilizing its GPCR
structure-based drug design platform technology, Sosei has
established a product pipeline with first/best in class potential.
Through development and commercialization partnerships, Sosei has
already delivered two bronchodilators for COPD which generate
significant and stable revenue streams that enable further growth.
Sosei partners include Novartis, Allergan, AstraZeneca, MedImmune,
MorphoSys, Teva, and Pfizer and we are actively looking for new
partnerships to enhance the development of our products and help us
deliver them to patients worldwide.
For further information about Sosei, please visit
http://www.sosei.com/en/.
Sosei Group Corporate Forward-looking statementsThis
press release contains forward-looking statements, including
statements about the discovery, development and commercialisation
of products. Various risks may cause Sosei’s actual results to
differ materially from those expressed or implied by the
forward-looking statements, including: adverse results in clinical
development programs; failure to obtain patent protection for
inventions; commercial limitations imposed by patents owned or
controlled by third parties; dependence upon strategic alliance
partners to develop and commercialise products and services;
difficulties or delays in obtaining regulatory approvals to market
products and services resulting from development efforts; the
requirement for substantial funding to conduct research and
development and to expand commercialisation activities; and product
initiatives by competitors. As a result of these factors,
prospective investors are cautioned not to rely on any
forward-looking statements. We disclaim any intention or obligation
to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
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Sosei Group CorporationChris Cargill, +44 (0)7912 892
199Head of Investor Relations and Corporate
Communicationsccargill@sosei.comorHarumi Banse,
+81-(0)3-5210-3399Investor Relations and Corporate Communications
(Japan)hbanse@sosei.com